Articles (Blog)
Medical Device QMS Blog
Practical guidance for MedTech teams navigating quality, compliance, and regulatory requirements.
Explore insights on medical device QMS, ISO 13485, risk management, FDA, EU MDR, traceability, CAPA, and other topics involved in building and maintaining a compliant medical device quality system.
QMS Manager: Job or Role?
QMS manager job or role: choosing a QMS ManagerRisk and QMS management: 2-in-1 or not?Choosing a Risk ManagerWhy the QMS Manager Job or Role Must...
Management Through Quality, an Innovative Approach to Collaborative Compliance
Software as an industry is unique in that not only can it be a product it can also be a service. Moreover, it is its...
Understanding Roles & Processes in ISO 13485:2016
What is a role and how does it connect to processes? The 2016 edition is much more complicated than the 2003 edition so here is...
Email is a Team Killer
Your email address is the proverbial key to the internet. No email address, no account at Facebook, no streaming, no whitepapers, no downloads. Whether you...
ISO 13485:2016 – New terms to take note of
Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions. ISO 13485:2003 only had a few defined terms with clear definitions. However, in the...
ISO 13485:2016 – Creating a Glass Ceiling for Startups
May 2016 was a dark period for medical small companies and startups, it was the day the ISO created a glass ceiling for Medical Startups. A glass ceiling!...
Wrapper – Let’s Start Managing Through Quality
An innovative approach to tackle the challenges of modern business - Management Through Quality™ qmsWrapper is a smart management software that effectively avoids adding another layer...
