3 ms·
In the medical devices field we have standards like ISO 13485 and IEC 62304. They are very broad and high-level standards and require a lot of interpretation. W
by jtwaleson 6y ago
In the medical devices field we have standards like ISO 13485 and IEC 62304. They are very broad and high-level standards and require a lot of interpretation. What would REALLY help small companies that are just getting started, is a line by line explanation of what you need to do, why, and what possible solutions there are. I'm not sure, but I believe doing so could violate the copyright. Even the fact that I'm not sure prevents me from doing it.
- chii 6y ago> a line by line explanation of what you need to do, why, and what possible solutions there are. That's where expensive consultants who already have interpreted the standards are paid to explain to you. It's a bit of a "cartel" imho.
- jtwaleson 6y agoYes, and each one will tell you something different ;) I much prefer open discussion where the best ideas stay afloat and bad advice can be publicly shamed.