Jamaica Private Tours

Jamaica Private Tours

Jamaica is an island that offers something special for everyone. The northern coast of Jamaica is loaded with excursions, that are suited for every type of visitors to enjoy. Regardless of the nature of your vacation, whether you arrived on a cruise or by air. Or, if you will be a guest for a few hours or for several days; Your accommodation could be at one of the many all-inclusive resorts on the island, at a villa in the hills or by the sea; there is undoubtedly something for you.
Jamaica is an intriguing island with a rich history that has given birth to Reggae Music and gifted a delicious array of culinary selections to include the famed, Jerk Chicken, Sumptuous Beef Patties, warm and friendly people with infectious smiles. It is the land of beautiful beaches, rolling mountains and majestic waterfalls. It is also known for its great coffee, Blue Mountain, rum and fast runners. Whatever adventure you are looking for you can find it in Jamaica.

 

Like other tourist destinations you may hear of, or may have visited, transportation is an important part of the vacation experience. There are usually several options available for travel when in Jamaica. On one hand, there are big tour coach buses in Jamaica that offer tours to many of the popular attractions. These tours are normally good, but can loose the great-effect, especially because there are too many personalities to be managed. They usually lack flexibility and so it somewhat more ridged. On these group tours, there is normally a schedule, but the tour can sometimes go at a slower pace than is expected, and so can be a bit infuriating and inconvenient for as some persons.

It is always great to have choices, so, on the other side of the coin, there is the private tours catering to your unique and specialized needs. For most guests, this is certainly a better experience because you get to enjoy the company of your group members in a more intimate space; you all get to control the outcome of your adventure. Customized private tours Jamaica permit guests to touch, feel and see the culture of the island in a way that is not available when you travel on group tours. Tours are enhanced when there is a private driver who will more or less become a friend for the day. The treats are better because the focus is totally on your party regardless of the size.

Each traveler has different interests and has peculiar ways of having fun. Being from different walks of life, and having different perspectives on life, your tours should be able to accommodate and reflect that too. Considering this, a small tweak on a private tour could make all the difference- this is what a private tour offers and much, much more.

How to Pack your Backpack like a Pro

How to Pack your Backpack like a Pro

Your adventure is fast approaching and you’re buzzing to get out there to conquer immense peaks and discover as many remote mountaintops, monuments and markets (which are normally seen only by local eyes!) as you can. You’ll only be able to make it there on your own two feet, with everything you need strapped to your back. Therefore the planning is crucial. Here are a few tops tips to bear in mind.
The Backpack is your Turtle Shell

 

This huge bulky beast will become your home and wardrobe on your journey, and so you need to make sure you get one that meets your purposes. Pop into any decent mountain or outdoors shop and there are always friendly and enthusiastic staff on-hand to help you pick out the best bag for you.

Before you Begin Packing

Before you even think about trying to master Tetris by jamming everything in, make sure you have all the essential gear. Make sure to grab a good backpacking checklist off the internet and then lay everything out in the following categories…

1) Most frequently used 2) Least frequently used 3) Heaviest gear 4) Lightest gear

Once you’ve got it all laid out it will be easier to start slotting things away in an order that makes sense. We find this method the most useful:

1) Frequently used stuff on the top (easy to reach) 2) Less frequently used stuff on the bottom (not in the way during the day) 3) Heavier gear closer to your back (you won’t feel it so much here) 4) Lighter gear away from your back (it doesn’t require as much support)

Compartments are your Friend

The Bottom is the perfect spot for bulkier items you won’t need until you camp. Think sleeping bag, sleeping mat, cold weather layers and your dry boots or shoes.

The Core Part is where you’ll want to keep heavier gear that you won’t need during your hike. This will include your tent and cooking kits, water and food.

Top Part of the pack is where you should stow things you’re going to need a lot during the day, including a fleece, your water filter, a first aid kit and loo supplies.

Accessory Pockets are where you keep the bits and pieces you need at a moment’s notice. This is the home for your sun cream, SPF lip balm, sunglasses, water bottle, bug spray, compass, the all-important snacks, ID and cash.

Loops and Lash-ons are key for those items which are easier strapped on than stuffed into your bag such as tent poles, hiking poles, rope and camping stools.

Just a Guideline!

Your exact needs will vary on the region you’re exploring and the time of year you’ll be there. Make sure to read up on what you’ll need and be prepared. Remember that for any backpacker, travel insurance should be the first item you organise. There are many types of backpacker travel insurance, and our team at Let’s Go Insure can help you find the one to suit your needs.

Author Plate

Feel the Thrill of a French Ryder Cup

Feel the Thrill of a French Ryder Cup

A Ryder Cup on the Continent is a rare thing. The last time the United States and Europe tussled on European soil was in 1997 at Valderrama Golf Club in Spain. That edition was a nail-biter, with the home team narrowly coming through by a margin of 14½ to 13½. Next year, however, the event will return to Europe once again: the Albatros Course of Le Golf National in Saint-Quentin-en-Yvelines will serve as the venue from 28 to 30 September.
To make the most of the upcoming Ryder Cup, 2018 will see European Waterways offering golf fans and Francophiles alike a wonderful opportunity: a chartered golf cruise through France and the chance to be at Le Golf National to watch the world’s best competing for the game’s most coveted trophy. Here’s hoping that the 42nd Ryder Cup will be just as exciting and dramatic the one in 1997!

 

Enhance your Game on the Renaissance

Whether you choose to embark before the tournament begins to get you in the mood or decide to join a charter after the final putt is made, the hotel barge Renaissance will make sure you have many opportunities to hone your own game. As Renaissance wends its way along the Loire, it will stop at a number of quintessentially Gallic courses, such as at Château Cely and Fontainebleau.

The Ryder Cup is always a special event, but we think that next year’s is going to be a particularly exceptional one. 2018 is going to be the year when our dedicated European golf cruise truly comes into its own.

Home Soil – A Home Win?

To get your appetite whetted in advance, here’s a preview of the Ryder Cup 2018. Having comfortably beaten the European contingent with 17 points to 11 at the Hazeltine National Golf Club in Minnesota in 2016, the Americans, led by Jim Furyk, will be hoping to retain the Cup for the first time since 1993. Under the captaincy of Danish golfer Thomas Bjørn, Europe will hope that playing on home soil and the backing of the crowd will spur them on to wrest back the Cup.

As for the venue, the 18-hole L’Albatros is certainly a course befitting of such an illustrious competition. British golfer Lee Westwood encapsulated the thoughts of many of his fellow players when stating that it is his “favourite course in Europe” and that it “would make a great Ryder Cup venue”. Finished in 1990, it has acquired something of a reputation for its final 4 holes. The various water challenges to be found here are sure to test the mettle of players from both sides throughout the Ryder Cup – 2018 could see a real classic. There’ll be no such challenges for spectators, though, as L’Albatros is widely considered to provide one of the best viewing experiences in the world.

Paul Newman is the Marketing and E-Systems Executive for European Waterways, the UK’s most respected provider of all-inclusive, luxury barge holidays, which can be booked to coincide with unmissable sporting events such as the Ryder Cup 2018 or the tennis French Open. Part of a team of experienced barging aficionados, Paul is first in line to endorse the perks of a slow-paced barge cruise to anyone looking for a unique holiday experience.

The Mood of purple

The Mood of purple

It has been found that certain colors have an effect on our mood. Colors at the red end of the spectrum are considered warm while the blue shades are cool. We will deal with the color purple which is contains both a warm red and a cool blue. Talk about mixed emotions! Are you a red purple or a blue purple?

The Mood of purple The Mood of purple

Red is a warm color and associated with strong emotions such love, comfort and warmth. While red seems to evoke these strong positive feelings it also appears to exacerbate strong or negative feelings such as anger or wrath. The color red apparently intensifies our emotions whatever they be. Red makes some persons feel confident and powerful and we wear it if we want to be noticed. Red is used to decorate certain rooms in the home. It is said to stimulate the appetite when used in the dining room or kitchen.

At the other end of the color spectrum is blue which has a cooling and calming effect. Imagine how it makes you feel to look out at a cloudless light blue sky. It is also associated with intelligence and productivity. For this reason it is often used to decorate the office. Because of its calming effect blue very often decorates the bedroom. Blue is non threatening and is viewed as a sign of reliability and stability. It is also a favorite color of many so is considered conservative. In the center of this color wheel we find the color purple which is most often associated with wealth and royalty. According to some authorities on color psychology the color purple is a balance between the two primary colors of red and blue. So, one would expect it to have a stabilizing effect on our emotions. But maybe that is the reason it is considered to be so mysterious by some. Is our mood swayed by the intensity of red or the amount of blue in the certain shades of purple?

Wisdom and spirituality are often associated with purple. In ancient times purple was extremely expensive and could only be afforded by the most affluent of persons. The reason for this is because it rarely occurs in nature and in those days was very hard to produce. Hence, only the very wealthy could obtain purple clothes or other purple things.

Purple is liked by both women and men and is often used in decorating. It has a calming effect on both mind and nerves and yet is emotionally uplifting and stimulates creativity.

Wisdom and spirituality are often associated with purple. Purple, it appears, has the qualities of both red and blue. Purple has several shades each having a different meaning. Light purple or lavender is feminine and romantic. Bright purple is the shade most often attributed to wealth and royalty. Dark purple is believed to evoke sadness and frustration.

Irritability and arrogance, it is believed, are brought on by too much purple, even making one impatient with others. Too little purple brings about apathy and negative feelings.

So, are you as confused as I am when it comes to decorating your home of office with purple? Do you like to wear purple? I started this article with the intention of blending the moods evoked by red and blue into one blended mood associated with purple.

In closing it appears that one should keep in mind the different shades of purple when using them in the color scheme. It seems that you can have purple in any room of the house or even wear all the purple you want. Just be mindful of the effect certain shades can have on the mood.

So, are you as confused as I am when it comes to decorating your home of office with purple? Do you like to wear purple? I started this article with the intention of blending the moods evoked by red and blue into one blended mood associated with purple.

In closing it appears that one should keep in mind the different shades of purple when using them in the color scheme. It seems that you can have purple in any room of the house or even wear all the purple you want. Just be mindful of the effect certain shades can have on the mood.

Katy Beacher is a retired registered nurse and grandmother with a lifetime of experience in homemaking and decorating on a budget. She currently runs a website endlesscoastaldecor.com where home décor items are sold.

Knowing The Man Behind Global Aviation Infrastructure

Knowing The Man Behind Global Aviation Infrastructure

Global Aviation Infrastructure LLC, a firm that is known for its management and advisory services in the aviation sector, was founded by Mr. Steven Levesque. Mr. Levesque has more than two decades of experience in the industry and has worked as a senior executive, most recently as CFO and CEO, for several private equity portfolio aviation companies.
Mr. Steven P. Levesque graduated from the University of North Carolina with a degree in business administration in 1989. He was commissioned as an Ensign in the U.S. Navy and served in various active duty and reserve capacities for over 25 years, including as Commanding Officer of a commissioned expeditionary logistics unit. He joined Hawthorne Aviation in 1995 served in various management and executive capacities at Hawthorne, Piedmont Hawthorne and Landmark Aviation.

 

Highlights include CFO of an $850 million revenue aerospace company and most recently serving as CEO of a new general aviation services company and Fixed Base Operation (FBO) platform with capabilities in aircraft Maintenance, Repair and Overhaul (MRO) and Aircraft Charter and Management (ACM). Steven Levesque’s international aviation experience includes development and management projects in India, Europe and the Middle East. Focus areas include development and operations of airport infrastructure in the FBO, MRO and ACM areas as well as the development of airport facilities.

Global Aviation Infrastructure, LLC

At Global Aviation Infrastructure, LLC, Mr. Levesque focuses on working with aviation asset owners to maximize the value of their aviation holdings through the use of industry leading best practices, scalable enterprise solutions and business model innovation. Specifically, Global Aviation Infrastructure, LLC concentrates on providing Fixed Base Operation (FBO), Maintenance Repair and Overhaul (MRO), Aircraft Charter and Management (ACM), and aviation infrastructure management for aviation asset owners, corporations, airports, private equity firms, family offices and financial institutions. Mr. Levesque firmly believes in the power of the industry and sees both continued growth and consolidation in the industry. Global Aviation Infrastructure offers a wide range of services to meet the diverse needs of aviation asset owners, from turnkey project management to customized structures which address the complex competitive landscape facing owners and investors. Contact Aviation Infrastructure Management Specialist Global

First wooden free-form houses Museum of Bread!

First wooden free-form houses Museum of Bread!

COOP HIMMELB(L)AU designed PANEUM – Wunderkammer des Brotes is the first wooden building in free form!
Meticulously planned, this customer information centre and event forum for the company Backaldrin in Asten, Austria, is an iconic structure comprising two elements: a box-shaped plinth building with foyer and event rooms that can be used for a variety of presentations, receptions or workshops for up to 120 visitors and the Wunderkammer des Brotes (Museum of Bread), a two-storey freeform exhibition area floating on top. The square base building shows a cast-in-place concrete façade while the rounded wood structure of the museum is clad with stainless steel shingles.

 

A centrally chiselled circular atrium is at once the cynosure of all eyes as it is flanked by a robust spiral staircase that invites visitors to pause awhile and take in the exhibited items from various perspectives. The stair provides access to the two exhibition levels, where the objects are displayed with the help of walls, tables, and cabinets that are integrated into the architecture. It further allows for striking vertical displays that take on a chandelier-like appearance, adding on to the visual appeal of the commanding building. The raw aesthetic of the interior is augmented by its self-supporting wood shell with its layers of cross-laminated timber and the natural light that filters in from above the atrium. This method of construction enables the realization of the free form and the high degree of prefabrication with 3D CNC technology that is precision-driven and cuts valuable construction time. It is a step into the future of construction; as Design Principal, COOP HIMMELB(L)AU, Wolf D. Prix says, “3D plotting, 3D milling and building with robots – that is the future of building.”

All Ski and Smile: Best Snowy Resorts for Families

All Ski and Smile: Best Snowy Resorts for Families

For families, choosing the right ski resort is the most important part in planning a sporty winter vacation. To ensure that everyone is happy, there are many things to consider, from accommodation to childcare. This can be a difficult and complicated task even for veteran travelers. To help, here are some things to look out for.
Guaranteed Snow – The ski season can be long, sometimes too long, and the tour company can persuade you cheaply off-season – but then you do not find snow when you get there. No one will suck energy from a party like turning on and finding no snow, so it’s always useful to consult an independent site beforehand. All Ski and Smile: Best Snowy Resorts for Families

Travel – No one likes to travel, especially small children. We recommend that you keep the trip to a minimum; This means shorter flights and shorter transfers. A resort far overseas may be cheaper, but is it worth deliberate?

Accommodation – Good quality, family friendly accommodation is your top priority. Although a little expensive to start, the lay lodges end up saving money for a week and making the holidays easier for the tired kids and their parents.

Nursery and Ski School – The resort you choose should have a slope for all abilities. If your kids do not have a good skiing experience, it’s also a good idea to check if the resort has breeding and ski schools that are reputable yet affordable.

Off-Piste Activities – On a week-long journey in the mountains, everyone will need to rest from the slopes as often as possible. Make sure that your resort has many off-piste actions, such as swimming pools, sleds or animal farms.

Best Resorts:

With all the factors considered, here are some of the best resorts for families.

La Plagne, France – La Plagne is a large ski area scattered in ten different villages, each with many villas and at least one nursery. There is also a ski school or two in each village, some of which are managed by Englishmen to help the language barrier.

Ylläs, Finland – For the more Christalm atmosphere the kids love, head to Ylläs in Finland. The resort has your off-piste activities covered, offering snowshoeing, deer sleigh rides and sledging. The accommodation here is not right on the slopes, which means that the villa is quieter at night and everyone gets more sleep.

Klosters, Switzerland – Klosters has a reputation for family fun like no other. This is mainly due to Madrisa Land, Switzerland’s largest adventure park on Mount Sonnberg Klosters. The park contains many additional safe areas for children to have fun with the ancient snowball fight and more.

Alpbach, Austria – A cozy little resort, Alpach is very popular amongst British families looking for a less hectic skiing holiday. There are many cottage options built right next to the ski nursery, which is perfect for small children. All Ski and Smile: Best Snowy Resorts for Families

Belinda Smythson works for Ski Amis, a specialist ski travel agency and booking service that has helped avid skiers and hikers make their perfect winter breaks for more than a quarter of a century. If you are looking for catered chalets, La Plagne is an ideal choice. For accommodation anywhere in Three Valleys, Paradiski, Espace Killy or Chamonix Valley, Ski Amis is a go-to company for winter sports enthusiasts looking for a lifelong holiday. All Ski and Smile: Best Snowy Resorts for Families

A Wild Walker Winter Come True Dream!

A Wild Walker Winter Come True Dream!

Winter sports fanatics can quickly become exhausted with the normal activities on offer. For those who crave a call that is really exciting and close to nature, leave skiing in this winter chalet. Walking on the ice and the thrill of every crunch under your feet on the glacier should be the next winter adventure. Glued to the screen at the end of your seat, you have watched a documentary about people climbing the ice, so now is the time to bring the sensation to yourself: try climbing the glacier for a unique experience that has additional benefits. takes place amid some of nature’s most beautiful natural sites. A Wild Walker Winter Come True Dream!
Franz Josef Glacier, New Zealand

The world-famous glacier is only accessible by helicopter, so all the ducks lined up to visit here to be one of the most amazing trips to mark your bucket travel list. Thisglacier continues to move, so the surging streams and floods and falling ice and rock slides are not uncommon. Be sure to check accessibility before you make your way there. But once you’re out there on the ice surrounded by a network of ice niches, blue ice and ice caves, you’ll be burdened by your own sincere feelings in the face of this big and powerful glacier. A Wild Walker Winter Come True Dream!

Chadar Trek, Ladakh, India

This lifelong Indian adventure is a challenge for those who like their difficult treks. The 100km-long 9-12 day journey has a ‘tough’ rating and not for a weak person. You will walk on the frozen Zanskar River, and may even be able to see the icy cold water pouring beneath the ice-frosted layer like the glass where you stand. This is truly an unending adventure: you will be camping in caves along the way and carrying all your own gear. It really is a baptism of fire (or ice!).

Maligne Canyon Icewalk, Canada

If you’d rather have more ice decomposing than plunging into Chadar Trek, then this two hour icewalk complies with the doctor’s orders. High-quality equipment including necessary boots and ice is offered on-site, so you are free to explore frozen waterfalls, towering ice pillars and underground caves in Maligne Canyon Icewalk safely.

Glacier gray, china

Chilean patagonia is bound to make this list, and Gray Glacier is often regarded as the eighth wonder of the world. The glacier itself and surrounding area is very beautiful. There are a number of hiking routes with varying degrees of difficulty leading to the glacier, with some very challenging treks offered for the toughest explorer out there! Strong winds, freezing temperatures and terrain that try to beat you before you even make it to the ice run, but still survive. The mesmerizingly beautiful landscape at the end is more than worth it. A Wild Walker Winter Come True Dream!

Insurance against Use and Tears …

If you have your sights on ice hiking at this destination or elsewhere, you will need winter travel insurance. While the most common policies can be expensive and limiting, there are renowned winter holiday insurance providers such as Let’s Go Insure that offer affordable rates for ice trekking and related activities. With the right insurance rates, even the most famous powdered dog and sensual seeker hunter can go through their own winter wonderland scenario with peace of mind. A Wild Walker Winter Come True Dream!

Ethan Bailey is an experienced adventure traveler and insurance expert with Let’s Go Insure team. Ethan’s spirit is to inspire his clients to go further, deeper and higher on their journey and his expertise in providing ideal insurance allows them to do just that. If you are looking for the best winter sports insurance Let’s Go works with the most experienced underwriters, intermediaries and insurers to offer competitive insurance without sacrificing protection.

A Lad’s Ski Break in Morzine

A Lad’s Ski Break in Morzine

Listen up skiers! Summer’s heading for the exit and you know what that means. You, your best mates and some ski runs to conquer…
That’s all nice and simple, but there’s still the tricky choice of where to go. There are loads of great ski resorts to choose from in Europe, each with their own incredible set of pistes and happening après-ski scene. Want my advice? For me, the only way is Morzine in the huge 650km Portes du Soleil area: a scintillating selection of runs (ranging from intermediate to expert), and off the snow entertainment that’s perfect for both party animals and more laid-back customers. You can thank me later.

 

Ripping Après Ski

When the sun sets on Morzine it becomes one hell of a party town. And because it’s not too big, wherever the night starts your next port of call is probably just around the corner. These are my picks (discovered through detailed ‘research’) of the best joints.

• The Tibetan Café – start the evening’s entertainment at this energetic spot. • Bar Robinson – one of Morzine’s most popular bars is a great place to take things up a notch. • Dixie Bar – chillers will dig this easy-going sports bar and its live music. • The Cavern – want to party into the small hours? Look no further. • Le Crepu – open till 2am and just right for winding down after a heavy night.

Some Awesome Skiing

Morzine is in the heart of the Portes du Soleil, meaning you have the pick of as much as 650km of pistes, just waiting to be tackled. With this selection of the best areas to go, there’s bound to be something for everyone in the group.

• Avoriaz – freestylers rejoice! This nearby resort has six terrain parks as well as plenty of gnarly high-altitude powder runs to strut your stuff. • Le Pleney – close to Morzine and with a great spread of blues, challenging reds and steep wide runs, Le Pleney is perfect for intermediates in search of real challenges. • Les Gets – high-altitude powder runs are the name of the game here.

And Still More Fun

If you fancy a day or two’s break from the skiing but can’t bring yourself to abandon the snow all together, then why not have a go at snowmobiling (either solo or with a guide depending on your confidence), ice skating or snowshoeing? Even winter paragliding’s an option. Believe me when I say it’s completely unlike anything you’ll have done before.

Morzine also has an active entertainment and leisure scene off the slopes. With a cinema, indoor swimming pool, ice-hockey games every week and spa treatments there’s no chance of boredom striking.

How to Get There

Getting to Morzine with Shuttle Direct is like going down a green run. Easy. Pre-book a Geneva to Morzine transfer and once you’ve arrived at Geneva airport, one of our friendly drivers will be waiting for you. As you and your mates travel from Geneva to Morzine, transfer your mind to thoughts of long days of skiing and lively nights of top-notch après ski.

Complaint Handling, Adverse Event Reporting, and Recalls

Complaint Handling, Adverse Event Reporting, and Recalls

Medical device makers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, ISO 13485: 2016, recognizes this fact. Different requirements of each regulatory system require manufacturers to identify their roles, as well as regulatory requirements for the role, and then incorporate them into their Quality Management System. Various jurisdictions, however, address the problem of post-market devices in various ways. Complaint management, reporting of adverse events and withdrawals are three interrelated and interrelated processes that need to enter SMM. Corrective action and design changes, which support the QMS process; also need to complete these three processes. And then, the regulatory requirements, which typically involve areas such as recording and reporting, are also entered. Course on how to implement an integrated QMS GlobalCompliancePanel, a leading professional training provider for all regulatory compliance areas, organizes excellently educational and valuable learning sessions about these primary and secondary SMM processes and how they need to be understood and implemented in conjunction with US, EU, and Canada. Dan O’Leary, president of Ombu Enterprises, LLC, a company that offers training and implementation in Operational Excellence, which focuses on analytical skills and systems approach to operations management, will be the director of this two-day seminar. And brings more than 30 years of experience in the field of quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical laboratories. Want to benefit from Dan’s rich experience and want to understand how to implement integrated SMM where various aspects of  Complaint Handling, Adverse Event Reporting, and Recalls  complaints, reporting and adverse withdrawal are built? Please sign up for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900960SEMINAR?Article-SEO. The seminar was approved by RAPS eligible for 12 credits against RAC recertification after completion. Alignment with FDA FDA The degree of alignment with the requirements of the FDA Quality Management System (QMS) is an interesting one from the final version of the ISO 13485: 2016 standard, which is now available. The alignment rate set at 2016 versions in 13485 may be much higher than the previous version of 2003; However, there are still some points where it deviates from the FDA QMS. Companies that must comply with these standards should keep this in mind. Now after ISO 13485: 2016, the Medical Single Audit System (MDSAP), and the new EU Medical Device Regulations have been introduced; companies need to update their QMS and integrate all elements if their implementation is to be effective and appropriate. In this two-day session, Dan will provide the tools the participants need for this. The agenda of this learning session is as follows: • Regulatory Structure? FDA QSR? ISO 13485: 2016 and regional variants? ISO 14971: 2007 and regional variants? Implementing MDSAP? EU Medical Device Regulations • Maintenance? Identification of problems ? Serving data analysis? Feedback to the grievance process • Complaint Identify complaints? Evaluate a complaint? Investigating a complaint? Complaint data analysis? Put it into a corrective action process? Feedback to risk management process • Corrective Action? Develop the process? Analyze product and process information? Determine the next action? Put it into the design process? Feedback to risk management process • Design and Design Change? Determining the need for design changes? Documenting the design changes? Design change verification and validation? Feedback to the risk management process? Input into the pre-market delivery process • Risk Management? ISO 14971: 2007 and regional variants? Entering post market information • Updating Pre-Market Submissions? US – Guide 510 (k)? EU – Technical files and design documents? Canada – License change • Bad Event Reporting? US – MDR? EU Alert Reports? Canada – Mandatory Obligatory Reporting • Remember? US – Corrections and Removals? EU – Corrective Action of Field Safety? Canada – Remember Complaint Handling, Adverse Event Reporting, and Recalls