Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Tag Archives: Quality Management System
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.
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 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Both paper and digital paper are outdated approaches to medical device quality management.
4 Keys to Funding Your Medical Device
How will you make your company more attractive to investors?
