Articles (Blog)
Medical Device QMS Blog
Practical guidance for MedTech teams navigating quality, compliance, and regulatory requirements.
Explore insights on medical device QMS, ISO 13485, risk management, FDA, EU MDR, traceability, CAPA, and other topics involved in building and maintaining a compliant medical device quality system.
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...
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...
