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
Do you know how secure your documents really are?
Data loss or damage is costly, extremely risky and can affect your brand reputation. Perils might come in many forms, as natural disasters (e.g. hurricanes,...
Are MedDev companies ready for the ISO 13485:2016? “A Closer Look”
Surprisingly, this is a real and topical question. At every MedDev or MedTech oriented exhibition this is the off-stage topic, actually more like the main...
The Quality Manual Alias the Quality Bible or the Quality DNA
Document what you do and do what you document Quality Manual is the foundation and framework from where you build your organization. It is a...
The Ultimate Content List of Technical File for CE marking
You, as a medical device manufacturer, are responsible for gathering certain key information about your device for the CE mark. When we say key information,...
What if staying ISO and FDA compliant was easy?
In the previous article, we took a closer look at ISO13485:2016 and the pending doomsday scenario. In this article, I’ll take a closer look at...
8 things to know about CE approval process for Medical Devices
As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so....
Validating or Not Validating for Intended Use?
When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA.Although Validation for intended use documentation is...
10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
The most important part of the manual is the description of the QMS The quality manual provides a wide range of benefits for organizations. Besides,...
5 things you must know about CE Mark
CE mark? It’s a symbol, it’s a declaration, it’s a proof, it’s validation, it’s European. As a medical device manufacturer, you are aware of the...
