Stephan Buttron, Germany

Dipl.-Ing. Biomedical Engineering
Principal Medical Research Manager, Regulatory and Quality Services, NAMSA

Professional Experience:
• Results-oriented professional with over 20 years of progressively increasing responsibility and
demonstrated success achieving EU, US-FDA and worldwide Regulatory Medical Device approvals
and registrations.

• Effective and timely execution of business objectives with analytical skills, leadership and team
player qualities.

• Timely execution on Product Registrations/Approvals with Notified Bodies and Competent
Authorities in the European Union, US-FDA, Health Canada, South Americas and APACS countries

• Provided multiple international consulting services on regulatory strategy development to MD
manufacturers for a least burdensome pathway for FDA 510(k)/PMA and MDD-CE mark

• Successfully managed FDA pre-submission meetings for Investigational Device Exemption (IDE)

• Conducted several training and consulting services to MD manufacturers on a structured Risk
Management process according to EN ISO 14971 and MDD 93/42 as amended.

• Provided multiple training sessions to MD manufacturers on Medical Device Design & Development
challenges to comply with EN ISO 13485, MDD:M5 requirements and US-FDA 21CFR820.30
regulations on design controls.

• Review and improvement on design verification and pre-clinical test protocols and reports in
accordance with Product Development Plan and pertaining regulatory requirements.

• Successfully developed and implemented and maintained quality management systems in
compliance with EN ISO 13485, Canadian MDR and FDA-Quality System Regulation (QSR).

• Performed multiple Quality System Audits for medical device manufacturers to improve suitability,
effectiveness in compliance with the following regulations: EU MDD 93/42 as amended, US-FDA
21CFR820/803/806, Health Canada Medical Devices Regulations SOR/98-282 and J-PAL MHLW
Ordinance 169.

• BSi and TÜV Certified Lead Auditor for EN ISO 13485 Quality Management Systems and EN ISO
14971 Risk Management including Training Qualification for new and revised ISO 13485:2016
QMS requirements.

• Trained Medical Device Software Reviewer to determine compliance with:
- US-FDA Guidance General Principles of Software Validation and
- International Regulations (IEC 62304) on Medical Device Life-Cycle Software Development.

• Provided multiple FDA-QSR Inspections, CAPA follow-ups and remedial consulting services to
avoid time consuming FDA Warning Letters and/or further regulatory enforcement actions.