Promenade Software regulatory experts have decades of experience preparing the software portion of medical device regulatory submissions. We understand the goals, terminology, and logic of the regulatory bodies and have created a suite of example SOPs and design history file (DHF) documents that can serve as a template for you. Our template materials combine both IEC 62304 and FDA guidelines for class II and III (B and C) software documentation. They are designed to be clear, and concise, while providing full coverage for the software portion of your submission. Whether you are doing an IDE, 510k, PMA or CE submission, this package will provide the foundation on which you can prepare your software documentation as part of your Quality Management and Risk Management System.
Promenade Software offers a package that provides the groundwork for your own software design history file (DHF). The documents provided are examples and templates to kick-start your submission materials. The content should be replaced/filled in with the content that is applicable to your product.
If your have your own software team, you should establish software SOPs as part of your Quality Management System. Use our SOPs as a starting reference for IEC 62304 compliant software development practices.