Every company that produces medical devices has to plan for that time when they must present compliance evidence to the FDA auditor. Often the most difficult and time-consuming aspect of this process is sorting through the available documentation produced by the design and development team, including outputs from multiple software tools. Even in that best-case scenario (likely you have the added challenge of having to fill a few holes in the paper trail), assembling and delivering documentation that is comprehensive in its demonstration of risk management can be an arduous task.
When the auditor is reviewing the design and development history of your medical device they want to see the full story, from the original concept though post-production. They want to see all the angles from which you’ve examined your product, from internal actions items and decisions, to incorporation of market feedback, to safety analysis of similar products. And within that story, auditors want proof that you’ve taken action to ensure that risks that can’t be eliminated fall into an acceptable range.
Everyone–including the auditor!–wants a smooth audit process, to ensure the safety of the patient. So how can you easily produce comprehensive documentation and pass your compliance audit?
In our work with medical device companies, we’ve come up with these recommendations for using Jama in your development process. These techniques allow you to show full traceability between risks and design controls, making the task of proving compliance less daunting, less time-consuming, with the added benefit of having a positive impact on your product quality.
Use Jama to execute your risk management process
First, we recommend that you manage all design controls (requirements, risks, design specs and tests) in Jama, and synchronize data from other developer tools, such as JIRA, using the Jama Integrations Hub. This foundational set up will ensure end-to-end traceability and also ensure that all of your data is available for your audit documentation.
Also in this Jama instance, capture and manage specific medical device data pertinent to a future compliance audit, such as intended use of your product, patient and user needs, your risk management plan and any other information that defines the device, your product objectives, and information about similar products in the market.
Just like you manage requirements with Jama’s collaboration tools, you can also use Jama to execute your risk management process. This provides the team one area where they can go to understand how to document risks and what information needs to be collected, and prevents confusion around process that is vital for your FDA submissions.
To do this, we suggest you track risks as individual items. Complete a preliminary estimate of the risk by defining the probability of occurrence of the harm and the severity of that harm, and use the calculated risk priority number to assess if the risk is acceptable. As you define mitigations, use relationships to illustrate those in Jama, and then update the risk priority number post-mitigation.
Use Jama’s Review Center for both risk and design controls reviews, inviting feedback from subject matter experts and stakeholders. When anyone has questions about why a risk was estimated in a certain way, these reviews are the source of truth for why decisions were made. Using Review Center, along with documenting this information in the project space, allows teams to collaborate on risk definition (and add more as they arise), discuss mitigation plans and verification of test results, to collaborate on solutions and to finalize and document decisions.
When telling the story of your medical device’s development lifecycle to the FDA, it can be a struggle to organize the information in a cohesive manner. And if documentation is missing or decisions and action items aren’t recorded, these gaps could result in your product never reaching the market—or being pulled from the shelves. Using Jama creates much of the needed evidence and is an easy step to take that will save time and money in the long run.
More on managing risk in medical devices using Jama
Want to know more about how Jama manages risk in Jama? Check out this video to understand more. And if you’re ready to see how Jama can help you manage the development of your medical device start a free trial.
We’d love to hear how your teams manage documentation for compliance audits. Do you have stories about how your company passed audits for ISO 14971, ISO 13485 or 21 CFR Part 11? Our medical devices team is curious to hear about your methods for streamlining your submission process for compliance audits.