If you have downloaded the 175-page European Medical Device Regulation but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added a very easy-to-navigate MDR Table of Contents – all in a single PDF.
We’ve added internal links so you can quickly access every Chapter, Article, and Annex!… Read More
It is commonly said that a rising tide lifts all boats. However, when the tide recedes it leaves many boats stranded, and this is exactly how some medical device and IVD companies will feel over the next several years.
Just a few years ago, Notified Bodies (NBs) were bountiful, accommodating, and hungry, but times have changed. Today, you are more likely to be the one doing the selling in the hope that your NB will continue to serve you in a timely manner, if at all.… Read More
Unless something politically dramatic occurs soon, at 11:00 p.m on March 29, 2019 the United Kingdom’s uneasy relationship with the European Union will officially end. While the Chunnel and other non-physical links between the UK and Europe will remain intact, many economic links will be severed and UK residents will likely wake up as non-EU residents the next morning.
Medical device companies and UK-based Notified Bodies and Authorized Representatives have been gnashing their teeth even since the momentous vote by UK citizens. Will UK-based Notified Bodies such as BSI still be allowed to certify medical devices for CE and audit the quality management sytems of their manufacturer clients?… Read More
In this game, a high score is not the goal!
The MDSAP grading system (GHTF/SG3/N19:2012 – Nonconformity Grading System) was established to address inconsistencies from traditional audit grading approaches like “major finding,” “minor finding,” and “opportunity for improvement” by establishing objective criteria to characterize the significance of findings that can be easily shared among participating Regulatory Authorities (RAs).
How It Works
During an MDSAP Audit, nonconformities are assigned a grade/score of 1 to 5 that is calculated using a two-step grading system.… Read More
There are two things all our customers agree on: transitioning to the new EU Medical Device Regulation (MDR) won’t be easy, and you need to start your transition now if you’re going to meet the deadline.
We couldn’t agree more. The new EU MDR has a 3-year transition period and represents a considerable compliance challenge, but companies that start their transitions early and follow a solid, well-developed transition plan will find themselves with a competitive advantage. These organizations should also view the transition as an opportunity to add value to their business by using the transition period as an opportunity to improve overall processes and eliminate marginal and unnecessary products.… Read More