Navigate regulatory pathways with confidence and ease
We help you take the smoothest path to bringing your medical device to international markets.
Whether you're a startup seeking a streamlined compliance solution or a larger organization in need of specialized QARA support, partnering with seasoned experts provides a seamless, reliable path to achieving your goals.
Our Services
R&D - Medical Device Design
Design & Development File (DHF/DDF)
Risk Management (ISO 14971)
Medical Device Software (IEC 62304)
Medical Electrical Equipment (IEC 60601-1)
Usability Engineering (IEC 62366)
Biological Evaluation (ISO 10993)
GLP Animal Studies, Clinical Studies (GCP, ISO 14155)
Design Verification & Validation
Design Reviews & Design Transfer
Design Changes
Quality Management
Startup-friendly QMS / eQMS implementation
ISO 13485:2016, ISO 14971:2019, MDSAP audits
Computer System Validation (including 21 CFR Part 11)
Complaints, NCs, and CAPAs
Fractional QARA / R&D Lead
Regulatory Affairs
Regulatory planning and compliance
Regulatory submissions (IDE, 510k, De Novo)
FDA inspection readiness
Regulatory remediations (Deficiency letters, 483s, Warning letters)
About
Olivier brings over 25 years of experience designing high-quality class I, II, and III medical devices and successfully bringing them to international markets.
He holds a master's degree in Computer Science and is based in Boston, MA. Olivier combines deep technical expertise with strong regulatory leadership, having held roles ranging from R&D Engineer to Director of R&D, as well as serving as a QARA consultant for international clients and VP of Operations & QARA for multiple startups.
With a passion for creating smart, scalable processes, Olivier helps organizations navigate complexity while maintaining compliance, efficiency, and innovation.
His services range from targeted QARA support to fractional QARA Executive and R&D Leadership, enabling companies to scale with confidence.
Connect with Olivier at: olivier.kagan@kaizen-consult.com