What Are the Biggest Changes under EU MDR?
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Tag Archives: QMS
Ask the Expert: What Advantages Does a Pre-Assessment Offer?
A discussion with Geoff Wood about the advantages offered by having a pre-assessment before a Stage 1 and 2 Initial Audit.
Why You Must Have a Single Source of Truth for CAPA
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Why Medical Device Makers Need to Revamp How Products are Manufactured
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
EU MDR 101: Preparing Technical Documentation
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
An Intelligent Approach to Modernizing Quality Management Systems
Operating with an antiquated QMS raises your risk. Here’s what to consider when modernizing your system.
Engineers: How to Curb Quality Myths Now
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Paper Processes: Three Reasons It’s a Costly Business Move
Both paper and digital paper are outdated approaches to medical device quality management.
Top 3 Mistakes You Can Make When Adopting ISO 13485
Drop the checkbox mentality and embrace accountability and understanding.
