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
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,...
How CAPA should be verified?
“Efficiency without Effectiveness misses the PurposeEffectiveness without Efficiency misses all the ProfitEffectiveness with Efficiency brings Performance.”― Martin U. Ugwu Verifying the effectiveness of corrective and preventive...
Jira is now “wrapped” with qmsWrapper
Now Medical Device startups and small businesses that use Jira can be connected to qmsWrapper. This integration will help medical device companies reduce their development...
Correct way to follow procedures and processes
Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors...
A new Traceability Matrix so powerful, it becomes the products dashboard
TM is now more effective and useful feature that serves as a dashboard for product development leading to submission. You build your Traceability Matrix as...
QMS documentation – “What should I document?”
Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier, while incorrect documentation will bring...
