The following list is only applicable to the software and electronic hardware aspects of the device. There are many other specifications that are applicable to other areas. These are the documents and specifications that you need to be familiar with to develop an embedded system for a medical device.
One of the first places to start is with two FDA documents:
- “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” – This 20 page document gives you a good overview of what is required by the FDA for the software contained in Medical Devices.
- “Frequently Asked Questions on Recognition of Consensus Standards” – This 11 page document gives you a good idea of what the FDA is looking for in terms of industry standards to apply to your medical device
We have found the following IEC/ISO standards to be applicable to the medical devices we have developed:
- IEC 62304 Medical device software – Software life cycle processes – This is the standard to start with because it outlines the relationship between it and the next three standards. It also lays out pretty clearly what you need to have in place to develop a medical device. Read more about MicroTools’ implementation of IEC 62304 here.
- IEC 60601-1 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance. Of particular interest here are the requirements imposed on Programmable Electrical Medical Systems and their subsystems. Read more about MicroTools’ implementation of IEC 60601-1 here.
- ISO 14971 – Medical devices – Application of risk management to medical devices
- ISO 13485 Medical devices – Quality management systems – IEC 60601-1 does not require a full blown Quality Management System in accordance with ISO 13485. However, we are required to have in place procedures that document what we do and how we do it. In addition we are required to have periodic assessments demonstrating that these procedures and processes are being followed.