If you want to make the world a better place then healthcare is one of the best fields. However, if you are coming from the "normal" software world then MedTech can be very painful due to heavy regulations. This group exists to help companies in the Medical Devices that struggle with combining fast paced software and the regulated Medical Devices field.
Companies in the group provide Software-as-a-Medical-Device (SaMD) or have a large software portion in a Medical Device that will be frequently updated (as in, the waterfall model does not work).
People in the group can be from engineering, R&D, QA/RA, compliance, management. Or, if you're in a startup, you will do all of these ;)
Our goals are:
- to build a network of people and companies that want to help each other out
- to share best-practices, pitfalls and talk about our struggles, so that we can build better, faster and cheaper products
Our anti-goals are:
- to provide a platform for consultants or vendors to present their offerings. We will always be an independent industry group.
Struggles that we have in common are:
- how do I get my engineers working within a QMS?
- how do I combine my software tools and risk management?
- how do I speed up the development cycle while remaining compliant?
- what kind of changes do need to be agreed with Notified Bodies?
- how do I get ready for MDR?
- should I adopt an eQMS or do it paper based?
- how to apply ISO 13485 and IEC 62304 to our normal software development workflows?