510(k) Approval Process Checklist
In general, manufacturers of Class II medical devices are required to submit a 510(k) to the FDA. Medical devices that contain software components or are composed solely of software have particular steps to go through to achieve 510(k) compliance. With this free check list, you’ll learn the key elements necessary to get started on your submission, including:
- Summaries & statements
- Performance & safety testing
- Specific inclusions for software
- AND MORE!
IEC 62304 Software Safety Checklist
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
With this free checklist, you’ll learn the key elements necessary to get started on your submission, including:
- Processes & controls
- Performance & safety testing
- Specific inclusions for risk management
- AND MORE!