openregulatory

1. It's very difficult to get software certified as a medical device. The new EU regulation on medical devices (MDR) makes things significantly more complicated than under MDD. There are a lot of confusing standards and medical software development plan 62304 requirements which manufacturers must adhere to. This is especially daunting for startups. At minimum, compliance with ISO 13485, IEC 62304, 62366 and ISO 14971 is required. These standards specify processes and documentation requirements regarding quality management, software development, risk management and usability testing. Unfortunately, they are written in a very generic way which makes it quite hard to implement them. A huge consultant industry exists which helps companies become compliant; however, most consultants don't have specific software experience. Nowadays with cloud-based Software as a Service with Machine Learning, there are only very few people who understand the regulatory implications. OpenRegulatory is a unique, free collection of how-to guides and templates which enables startups to become compliant and bring their product to market - completely without having to rely on external consultants.