In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator.
Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation.
Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony.
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What is FDA Inspection Readiness?
FDA inspection readiness refers to the ongoing state of compliance and preparedness for an FDA audit or inspection. It involves having robust quality systems, complete documentation, and trained personnel to demonstrate adherence to applicable regulations and standards. This ensures that a company can efficiently respond to any FDA inquiries and avoid costly delays or compliance issues.
What are Design Controls?
Design controls are a set of quality practices and procedures integrated into the product development process to ensure that medical devices meet user needs, intended uses, and specified requirements. They include stages like design planning, design inputs and outputs, verification, validation, and design transfer.
Vincent Cafiso on LinkedIn
Etienne Nichols on LinkedIn
Creo Consulting: Vincent Cafiso’s current company offering regulatory and quality services to MedTech organizations.
FDA Guidance on Design Controls: Essential reading for understanding how to document and verify design history files.
Greenlight Guru's eQMS Software: A quality management system built specifically for the MedTech industry, aiding in compliance and product development.
Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
This episode is brought to you by Greenlight Guru, the only quality management software designed by MedTech professionals for MedTech companies. With a robust EQMS platform, Greenlight Guru helps streamline compliance and innovation processes, ensuring faster market access and safer medical devices. Visit greenlight.guru to learn more and schedule a demo today!
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...