The Role of Clinical Evaluation Reports (CER) in Medical Device QMS
Introduction The medical device industry is highly regulated, ensuring the safety and performance of devices…
Balancing the Past and Present: How Static Records and Living Records Drive Better Decisions
By Jackie Stapleton In 2021, I was working closely with a compliance officer named Mark,…
Embracing Diverse Thinkers: Strategies for Inclusive and Effective Collaboration
By Jackie Stapleton I had an experience within the last year that made me reflect…
Medical Device Recalls: Root Cause Analysis and Preventive Measures
By Gurpriya Kaur Introduction Medical device recalls are a critical element of ensuring patient safety…
New ISO 9001 Standard is Coming
ISO 9001:202X – 6th Edition Upcoming ISO 9001 Changes: What You Need to Know As…
Stop Pushing, Start Pulling: A Balanced Approach to Leadership in ISO Management Systems
By Jackie Stapleton Implementing an ISO Management System often comes with the misconception that everyone…
Successful Audit Formula
By Jackie Stapleton This is business of the 22nd century, where scrutiny on every element…
A Quick 10-Point Checklist for Managing Risks to Food Safety in a Storage & Distribution Environment
Ensuring the safety and integrity of stored and distributed food products is paramount to every…
What Is Change Management: A Quick Guide
In a world where change is the only constant, organizations can no longer afford to…
Why Sustainable Development Is Built on Quality
by Physikalisch-Technische Bundesanstalt (PTB) The world is full of colour and energy. Human ingenuity has…