Episode 7: Startups, Regulations, & Risk: Insights from MedTech Guru Etienne Nichols

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.