FDA Strategy: Improving the Safety of Medical Devices – Naomi Schwartz, VP, Services Medcrypt

In this interview, Naomi Schwartz, Vice President, Services at MedCrypt discusses the overall concerns with cybersecurity, the RTA policy, and improving the safety of medical devices.

The interview covers:–

0:13 – What are the overall concerns with cybersecurity and medical devices?

0:56 – Please tell us about the RTA policy.

1:34 – How serious is the FDA about the RTA strategy and what makes it different?

2:39 – What has changed about the final version of the FDA pre-market guidance?

4:03 – How should manufacturers be approaching and acting on the eStar and RTA guidelines from the FDA?

5:08 – What are some common challenges or hurdles they’ll face along the way?

5:55 – For device manufacturers who are ready to go to market, how long will this process take?

6:41 – How do regulators, industry stakeholders, and cybersecurity experts ensure the security of medical devices, and how can it be improved?