What are some of the key challenges MedTech companies face in balancing innovation with compliance?
This episode dives into the intersection of quality management and cybersecurity in the MedTech industry. Hosts Christian Espinosa and Trevor Slattery are joined by Etienne Nichols, an expert from Greenlight Guru, who shares insights on regulatory compliance, risk management, and the importance of designing cybersecurity into medical devices.
Key points:
* The importance of building cybersecurity into medical devices from the design phase.
* How quality management systems (QMS) streamline compliance and audits.
* The role of ISO 13485 in MedTech and its differences from ISO 9001.
* FDA’s growing focus on cybersecurity in regulatory submissions.
* The economic risks of poor documentation and lack of traceability.
* Best practices for startups in adopting right-sized QMS solutions.
* The relationship between quality assurance (QA) and regulatory affairs (RA).
* How risk management frameworks like ISO 14971 and TIR-57 intersect.
* Why hospitals demand cybersecurity assessments before purchasing devices.
Chapters:
(01:01) Meet Etienne Nichols
(03:04) The Basics of Quality Management Systems (QMS)
(05:19) How QMS Integrates with Cybersecurity
(08:17) Designing Cybersecurity into Medical Devices
(12:21) Understanding CAPA and Post-Market Risk Management
(17:19) Startups vs. Large Companies: QMS Challenges
(24:10) Bridging Quality and Cybersecurity in MedTech
Resources mentioned in this episode:
* Quality Is Free: The Art of Making Quality Certain, by Philip B. Crosby.
* ISO 13485 (International standard for medical devices QMS).
* ISO 9001 (General quality management system standard).
* ISO 14971 (Risk management for medical devices).
* TIR-57 (Security risk management for medical devices).
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com
If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session
Thanks to Etienne Nichols for being on the show. Connect with Etienne on LinkedIn: https://www.linkedin.com/in/etiennenichols/
Learn more about Greenlight Guru: https://www.greenlight.guru/
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Director of Medical Device Cybersecurity at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
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Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
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Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/
Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial
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