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
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...
ISO 13485:2016 Summary
Medical Devices – Quality Management System – Requirements for Regulatory Purposes The world’s most popular standard for medical device quality management has been revised for...
8 Secret Benefits of Using Team Collaboration Tools
That will Boost Your Company’s compliance productivity. Working in a team can be a communication challenge, from rallying people around a project, chatting constantly, losing attachments...
New Feature Announcement: “My Team”, for qmsWrapper
We are pleased to announce the release of the new team managing tool - My Team, in the Project Management Module for qmsWrapper. Projects are...
Design Methodology Process – the guide through compliant design change
So you want to design a new version of your medical device? Here’s what you need to do to ensure ISO and FDA compliance. As a...
Management Through Quality, documenting compliance activities
QMS, another layer of management or smart management. If you’re thinking that a QMS system would be just another layer of management, think again! It’s true that...
6 reasons why DM System makes a difference
In today’s modern world there is no space for time-wasting. The challenge of time was best expressed by William Penn when he said, “Time is...
Creative Collaboration, Collaborative Compliance
It’s official, workplace emails are an ineffective tool for managing projects. Don’t confuse Emailing a link to your team as collaboration - that’s ping-pong! And sending...
