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Showing posts tagged with: medical device

Top 10 medical device trade shows 2020 not to be missed

Top 10 medical device trade shows 2020 not to be missed

Tradeshows are an excellent opportunity for exhibiting the newest products and any kind of innovation that your company has made.  It’s perfect for brand awareness, as well, as for promoting your business. There is so much benefit to attend a trade show. We have listed 10 trade shows in the world for 2020, which we believe has...
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THE NEW MDR 2020 – all you need to know

THE NEW MDR 2020 – all you need to know

  TO ALL MEDICAL DEVICE MANUFACTURERS   The New regulation (not directive anymore) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away. Are you ready? We will give you a few handy pieces of information that will provide you a clearer image of what is requested and help you go...
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Cup of Joe 43# - Treat the cause, not the symptom

Cup of Joe 43# - Treat the cause, not the symptom

What is the root cause analysis? Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well. Basically, RCA is...
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Top 20 Medical Device Conferences and Trade Shows 2019

Top 20 Medical Device Conferences and Trade Shows 2019

The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, expand your industry contacts, recruit new employees, explore new product offerings, keep up on the latest regulatory trends,...
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Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

An effective traceability process is an essential requirement when developing medical device software and achieving regulatory compliance. How to create a Traceability Matrix? Traceability Matrix can be very difficult to create. It can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult, not to mention all...
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Understanding Roles & Processes in ISO 13485:2016

Understanding Roles & Processes in ISO 13485:2016

What is a role and how does it connect to processes?   The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and requirements compared with the 2003 edition. "First, a stab of the ISO bureaucrats…...
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