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
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...
Same Tasks over and over Again? Let a Workflow Process Help You.
In the world of standards, regulations and protocols it is really easy to get confused. They are complex and always changing. Often, the issue is...
QMS Expert vs QMS Expert…alias – Today Everybody is an Internet Certified QMS Expert
The newbie QMS Managers Conundrum – 5 things to identify the right Expert? As a newly minted QMS manager in a medical device startup, I...
Top Documentation Pain Points Solved With DM Software
Today’s businesses are up against more challenges than ever in the past. While some businesses think they don’t need to move away from paper, getting...
Risk as synonymous with uncertainty?
” Risk /rɪsk/, noun the possibility that something unpleasant or unwelcome will happen. Synonyms: chance, uncertainty, unpredictability, instability, riskiness…” We’re dealing with countless risks in...
Chat for Compliance – a hacker’s view!
This week we bring you a real-life experience example about how the qmsWrapper built-in chat function can turn the compliance documenting process into an easily...
