What Will Happen to UK-Based Notified Bodies and Authorized Representatives after Brexit?

Brexit-RA/QAUnless 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

Ready, Set, Score! Understanding the MDSAP Grading System

MDSAPIn 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

Transitioning to Europe’s New Medical Device Regulation (MDR)
It Doesn’t Have to Be a Struggle

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

How Quality System Harmonization Supports Growth

quality-system-harmonization

Do any of These Quality System Challenges Sound Familiar?

“Me too” nonconformances or 483 observations occurring in different areas of the business.

“We do it this way” responses that differ by area when you ask employees how they execute quality system requirements.

“I didn’t know that” responses when asked about an organizational quality goal.

“How will we roll this out across the company?” when there is a need to transition to new requirements such as MDSAP, the new European Union medical device regulations, and ISO 13485:2016.… Read More

MDSAP’s Process-Based Audit Approach

Oriel STAT A MATRIX can help answer your questions about the Medical Device Single Audit Program.

Short-Term Pain = Long-Term Gain

The MDSAP audit model uses a process-based approach and defines the required audit sequence, nonconformity grading, scoring mechanism, and time requirements per process. In addition, the auditors must examine regulatory requirements from multiple countries. While the MDSAP audit may be more difficult at first, the payoff is big: A single audit satisfies multiple regulatory authorities.

MDSAP’s Process-Based Audit Approach

MDSAP’s process-based approach is different from the traditional checklist-style audit that reviews documentation and conformance to standard requirements and procedures but it’s not new.… Read More

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