In the fast-paced world of medical device innovation, ensuring the security and compliance of your products is paramount. On September 27, 2023, the FDA released the final guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” This guidance demands rigorous attention to detail, cybersecurity readiness, and strategic planning. Medcrypt understands these challenges, and with our team of FDA and medical device experts, we’re here to guide you through the submission process seamlessly.
At Medcrypt, we offer a comprehensive range of services to support your regulatory readiness:
1. FDA Cybersecurity Filing Readiness Survey:
A free assessment for MDMs to gauge submission readiness by responding to survey questions aligned with the new FDA guidance, including responding to survey questions aligned with the new FDA guidance, with eSTAR for 510(k)s and optionally for de novo submissions, and with other refusal types for filings not submitted via eSTAR.. This service provides valuable insights into the risks to acceptance for the submission.
2. FDA Cybersecurity Filing Remediation:
For MDMs who do not pass the FDA Filing Readiness Survey or face an FDA refusal (e.g., RTA, RTF, AINN, MAJR, NSE, NOAP), Medcrypt’s experts can help identify cybersecurity gaps and create a prioritized plan to rectify issues, ensuring the submission’s cybersecurity content becomes acceptable.
3. FDA Cybersecurity Submission Readiness:
Designed for MDMs with submissions either already under FDA review or planned for the near future, this service offers a comprehensive review using Medcrypt’s unique five-sector framework (review of threat modeling, post-market management, vulnerability management, security risk assessment, and SBOM processes and outcomes) to ensure cybersecurity compliance.
4. FDA Cybersecurity Hold Letter Response:
In the event of an FDA hold letter, Medcrypt provides immediate guidance to navigate the response process effectively.
Our Unique Approach
What sets Medcrypt apart is our unique approach to cybersecurity readiness. Our knowledge gained from past submissions ensures insights into FDA expectations that benefit all Medical Device Manufacturers. This means that our expertise is continuously refined and updated based on real-world challenges and solutions.
The Benefits of Choosing Medcrypt
FDA Insights: With FDA leaders on our team, we offer unparalleled insights into the FDA’s expectations and requirements, ensuring your submission aligns with their standards.
Customized Solutions: We understand that every medical device is unique. Our services are tailored to your specific needs and the intricacies of your product.
Proven Expertise: Medcrypt’s track record in the industry speaks for itself. We’ve successfully guided numerous companies through the FDA submission process and helped them achieve compliance.
Comprehensive Support: From initial submission preparation to ongoing cybersecurity program development, we provide end-to-end support to safeguard your products.
Navigating the FDA submission process doesn’t have to be a daunting task. With Medcrypt’s experienced team by your side, you can streamline your submission preparation, prioritize cybersecurity remediation, and achieve program maturity. Our unique approach, coupled with a deep understanding of FDA expectations, ensures your medical devices are compliant and secure in an ever-evolving threat landscape. Trust Medcrypt to be your partner in achieving FDA cybersecurity readiness and ensuring the safety of your innovations.
Get the latest healthcare cybersecurity news right in your inbox.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
We'll never spam you or sell your information