Oct 14 (edited) • General discussion
Welcome! Introduce yourself + share a pic of your workspace 🎉
Let's get to know each other! Comment below sharing where you are in the world, a photo of your workspace, and something you like to do for fun. 😊
🚀 Introducing Myself: Your QARA Companion for Medical Devices and IVDs eventually ;)
Hello everyone, I'm Guillaume Saint-Pierre, and I'm thrilled to join and contribute to this community.
With over 16 years of experience in the medical device (MD) and in vitro diagnostic (IVD) fields, I've developed a true passion for translating complex regulations into effective, real-world quality systems.
My Journey: From Science to Strategic Quality
My career is founded on a unique blend of deep technical and regulatory expertise:
- The Scientific Foundation: I hold a PhD in Analytical Sciences and an MSc in Analytical Chemistry , giving me a strong base in biomaterials, ceramics for cell-based assays, and analytical method development. I've been hands-on in R&D, managing projects from concept to market in areas like micro electro-analytical medical devices and hydrogels for 3D cell culture.
- The Regulatory and Quality Leadership: I've served in leadership roles, including Quality Manager at Ceramaret SA , where I managed the QMS, led QA/QC teams, and oversaw audits. I also spent two years as a Client Manager/Lead Assessor at BSi Group , actively conducting audits for ISO 13485, MDSAP, MDD, and MDR , which gave me a detailed, practical view of a truly compliant QMS. More recently, as a Senior Consultant, I guided clients on regulatory strategy for the US and EU markets, focusing on technical documentation and risk management
My Commitment to the Community
My motivation to contribute here is simple: I want to move beyond a purely regulatory approach and share the practical knowledge needed to build a robust, results-driven QMS.
I believe my "double expertise" in science and regulation allows me to effectively bridge the gap between technical teams (R&D, Engineering) and regulatory requirements.
I'm here to help you with:
- MDR/IVDR, 21CFR and ISO 13485 , QMSR Implementation: Deep dives into Design Control, Risk Management, and Technical Documentation.
- Audit Readiness: Sharing best practices for internal, supplier, and Notified Body audits.
- Quality Culture: Practical strategies for continuous improvement and embedding quality in operations
I look forward to an engaging exchange of ideas! What's the single biggest QARA challenge your company is facing right now? Let's discuss it below! 👇
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Welcome! Introduce yourself + share a pic of your workspace 🎉
