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
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...
Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings
Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 9001, ISO13485, FDA510K) Nobody wants to hire...
Pitfalls and Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less... In...
How to stay on top of your product development and easily organize your FDA and CE submission
Traceability is required by regulations. Traceability Matrix Updated 2019, For FDA, 510(k), DeNovo or PMA, traceability is required as part of your Design History File...
Choosing a QMS system? Why you should seriously look at the new qmsWrapper!
The new version of qmsWrapper is updated in December 2019. We were still shaking from a disastrous ISO audit. Joe, the perennial QMS manager from...
Audit Day Fears are Gone! How Cardio-Phoenix carried out of an ISO Audit With Help from qmsWrapper
Audit – a word that inspires anxiety. Even when everything is well planned, and you think you are prepared, anticipation turns to anxiety, anxiety to...
Top 20 Medical Device Conferences and Trade Shows 2019
The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition,...
