Community resources
Community resources
- Community
- Tag: medical-device
Tag: "medical-device"
-
Picture this: You have just finished writing your requirements specification and saved it as “Requirements_final.doc” Then come the edits, code reviews, and compliance feedback. Suddenly you’re l...
-
Hazard analysis is the must-have risk management approach in medical device industry. While many companies stick with single probability values in their hazard analysis, ISO 14971 suggests b...
-
The EU AI Act is here – the world’s first major AI regulation, reshaping how companies build and use intelligent systems. For medical device software, this means tighter rules, higher expectations, a...
-
At SoftComply, we understand the importance of proper risk management. From costly design changes to product recalls and bad press, not accounting for risks is in fact the single biggest gamble tha...
-
A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the ...
-
The Role of Cybersecurity in Medical Device Safety The Global medical device market is a $800 billion business that is rapidly growing, especially in the area of software as a medical device (SaMD)...
-
There are some electronic records that a medical device manufacturer can easily manage in Confluence while others require a compliant document management solution. This post describes which records f...
-
All product development teams let out a sigh of relief when a product is launched. The hard technical work is done, tight deadlines met (more or less), submissions completed and approved. Time to han...
-
This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2...
-
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devic...
-
Your medical device software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Un...
-
Risk management in the Regulated Industries is often viewed as a necessary evil, but what if we approached it as a secret weapon instead? It's a common misconception that risk management slows down...
Copied to clipboard