Articles (Blog)
Medical Device QMS Blog
The qmsWrapper blog shares insights on medical device quality management systems, ISO 13485 compliance, regulatory frameworks, and practical guidance for MedTech teams building compliant products.
Topics we cover
- Medical Device QMS
- ISO 13485 Compliance
- Risk Management (ISO 14971)
- Regulatory Strategy (FDA, MDR, IVDR)
- Traceability & Design Control
- CAPA and Quality Events
5+1 Ways to Improve Team Collaboration
Elements of effective team collaboration & best practices Establishing and developing a productive and successful team can be tricky. Have your team ever struggled to collaborate...
6 Benefits of ISO Compliance
ISO’s standards are created to guide companies in dealing with some of the most demanding challenges of modern business – Quality & Customers. At its...
6 Things Your DM Software Should Have
ISO 12651-2 defines a document as "recorded information or object which can be treated as a unit". Err… Yup!... Got it!... Been treating recorded objects as...
7 Easiest Ways to Create a Championship Team Through Collaboration
“Individuals play the game, but teams win championships”Bill Parcells As in sport, the same rules apply to business. Collaboration is the glue that binds teams....
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...
