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 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...
Project management and quality management 2017 – smart solution
qmsWrapper is 1 system with 5 modules and if you thought project management couldn't include QMS... think again... In a global environment, companies are facing...
The Dawn of Integrated QMS… Part 2
qmsWrapper, the leading integrated QMS system specifically aimed at compliance qmsWrapper has Compliance in its DNA. Since developed by a medical device company, the priority was...
The Dawn of Integrated QMS… Part 1
Making the life of a startup easier As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a...
The Temptation of ISO 13485 Template Kits
Be careful what you use when building up your QMS system! The expanding Internet means more: more data, more collaboration, and more complex systems of...
