Medical Device Development Services
Medical device development consulting by Alan Cohen, author of the book Prototype to Product: A Practical Guide to Getting to Market (O’Reilly Media)
How can I help to maximize
IEC 62304 Coaching
I can help you to develop processes that minimize the effort and hassle of complying with the medical software standard recognized by the FDA and other regulatory bodies.
Design for Regulatory
Thoughtful device design can reduce the safety classification per FDA and other regulatory bodies. This can greatly reduce required documentation and testing.
“Expectations are the sole source of disappointments.” Good requirements ensure that everyone’s expectations are in sync — but they can be challenging to develop.
Along with good requirements, detailed and realistic project plans are the key to predictable development efforts. Like good requirements, they are challenging to create but pay back many multiples of their cost.
An independent expert for design reviews and documents helps to demonstrate care in decision making. This can be important during inspections and litigation.
Whether you need an expert in a specific area or an experienced team who can hit the ground running, I have a solid network of people and organizations that I can bring in to help solve problems quickly.