Meet our experts
Aymeric Lebon
Medtech Commercial Director
Aymeric specializes in Artificial Intelligence integrated into Medical Devices, IVD. Experienced in AI regulations, he ensured the definition of appropriate ways to manage IA-generated data to support their regulatory purpose, including IA impact on activities over the pharmaceutical products’ lifecycle. Formerly General Manager and Technical Director at Strategiqual, Aymeric supported startups and major companies for over a decade. His empathetic and communicative approach to change management makes him highly effective in project leadership, with expertise in European and international frameworks for supporting medical device and IVD companies in competitive markets.
Pascale Cousin
Chief Operation Officer and Senior Consultant – Strategiqual, a ProductLife Group Company
Pascale is Chief Operation Officer and Senior Consultant for the medical device and in vitro diagnostic device division of Strategiqual Pharmacist, former hospital intern, holder of a Master’s degree in Health Law, specializing in regulatory affairs for health products. She is expert in the regulation of medical devices and in vitro diagnostic devices Pascale joined Strategiqual 3 years ago after an industrial career and in professional organizations (SNITEM, SIDIV) and the order of pharmacists.
Our Medical Device and Medtech Services
Device Design and Development Support
MDR/IVDR Transition & Readiness Support
Quality Management System (QMS) support
Medical Device Regulatory Services
Post-Market Support in Medtech and IVD
Why Choose PLG as your Medical Device and Medtech partner?
Your partner in every stage of the MD/IVD product lifecycle journey
Our dynamic medtech and IVD industry solutions, including self-care medical devices, are designed to support manufacturers and stakeholders throughout the entire product lifecycle. Our expertise lies in quality and regulatory affairs with a strong focus on regulatory strategy, design control expertise, technical documentation, and MDR and IVDR transition support. We deliver tailored QMS support according to regulatory frameworks (ISO 13485, 21 CFR part 820, MDSAP), high-end regulatory services with main RA pillars, and post-market surveillance. With years of experience, our team can drive new innovative companies to deliver new solutions, providing flexibility, cost-effectiveness, and a dedicated commitment to driving technological advances to improve human health.
- We are globally present, covering different countries with our experts and partners, and committed to delivering successful and impactful outcomes.
- Our dedicated team’s deep understanding can help you with a strategic and lean approach to the world’s next-generation healthcare solutions.
- We provide hands-on experience across different types of devices (MD/IVD) and classes.