Finalize Product Documents

Verification/Validation Test Reports – These reports summarize the testing and results of your verification and validation testing. These secondary sources reference primary testing data from your bench testing and clinical studies, and include conclusions relating to accuracy, reliability, and safety.

Risk Management/FMEA – Whatever you learned during verification and validation needs to be incorporated into your risk management. Update your FMEA, FTA, and overall risk reduction measure matrices with data gathered with real time testing. Perhaps testing led to a change in design, supplier, or scope of device – this can all be captured in the risk management.

IQ/OQ/PQ – During Gage R&R, you should’ve conducted process (IQ) and tool (OQ) validation. Analyzing these methods helps determine performance qualification (PQ) – i.e., is the process stable and did it produce the correct results? Summarize the findings in process validation reports.

Technical Documentation (DHF, DHR, DMR, TF, GSPR) – All the design, development, manufacturing, and testing procedures, reports, and data need to be stored somewhere. You also need to summarize how everything you did meets all regulatory requirements for that device. The technical documentation is your device brain – it has everything you need to know about the device and more.

Labeling (IFU, Packaging) – The two most important things that you need to keep in mind while developing product labeling are regarding usability and safety. Warning letters and advisories against labeling are typically done so because safety issues and warnings are not adequate for communicating risks to patients. Take the time to do some usability testing and validation before you release any customer facing labeling.

Marketing Communications – Advertisements can get manufacturers in trouble quickly. It’s easy to stretch the truth to gain extra customers. Marketing communications should always be reviewed against device documentation to prevent false advertising and legal issues down the road.

Regulatory

510k/PMA, CE Mark, etc. – Depending on where you chose to market your device, you’re going to need to prepare several portfolios to document all the design and development activities you did during design controls. A regulatory specialist should compile and examine these portfolios to ensure nothing is missing and nothing will hang up your approval in the countries of your choice.

Patent Filing – If you haven’t already done so, now’s the time to make sure all your work is covered and saved in a legal sense. It’d be awful to spend all the time and money you have to make your device only to see someone else beat you to the patent and will reap the rewards.

EUDAMED Registrations – The new EU MDR required the development of an international database to log important information relating to medical devices. It’s not up and running yet (as of 2020), but plans are for it to be effective in the next year. Your regulatory and quality specialists should be involved in making sure you’ve dotted your I’s and crossed your T’s to get everything listed that should be.

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