Miklos Weszl
Wake Forest,NC
Summary
Seasoned medical-scientific professional with 15 years of cross-functional experience spanning clinical evaluation, regulatory compliance, and scientific writing in the medical device industry. Proven record of developing MDR-compliant Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) plans, and technical documentation for orthopedic and trauma implants. Combines clinical, scientific, and regulatory expertise with exceptional writing and analytical skills to deliver submission-ready, high-quality documents supporting global market access.
Overview
17
17
years of professional experience
Work History
Medical Device Lead Auditor & Product Expert
TÜV Rheinland North America
02.2023 - Current
- Lead auditor for global medical device manufacturers (50+ audits across U.S., and EU).
- Assess CERs, PMCF, SSCPs, and clinical evidence against MDR and MEDDEV requirements.
- Interface with regulatory, quality, and clinical teams to ensure alignment with EU and FDA expectations.
- Contribute to continuous improvement of clinical documentation templates and reviewer training.
- Remote
Technology Transfer Manager
University of Missouri
07.2022 - 07.2023
- Evaluated IP and commercial potential of 20+ biomedical technologies; mediated between patent attorneys and inventors.
Regulatory and Clinical Evidence Specialist
Independent Consultant
05.2018 - 02.2023
- Authored CERs, CEPs, PMCF plans/reports, and PSURs for orthopedic, dental, and telemedicine devices (100% CE mark success).
- Led systematic literature reviews and meta-analyses to establish device safety and performance.
- Coordinated clinical strategy, study protocol development, and data synthesis for prospective and retrospective studies.
- Collaborated with C-suite executives and clinicians; addressed notified body feedback and implemented corrective actions.
External Auditor / Technical Documentation Assessor
European Notified Bodies
06.2013 - 07.2022
- Conducted 100+ audits and assessments of Technical Documentation across orthopedic, spinal, and dental devices.
- Evaluated clinical evidence files (CERs, PMCF, risk management, biological evaluation) under MDD and MDR requirements.
- Provided detailed feedback to manufacturers and supported NB review process optimization.
Clinical Research Coordinator
Gedeon Richter Plc
06.2015 - 03.2016
- Coordinated Phase I bioequivalence clinical studies for generic drugs.
- Managed academic and industrial partners (CROs and university clinics).
- Developed process monitoring tools and achieved promotion to lead the Russian market segment (40% of company revenue).
Co-founder & CEO
ITM Kft
05.2010 - 09.2015
- Led EU-funded consortium (€1.2 M budget) developing antibacterial titanium nanosurfaces.
- Oversaw clinical and pre-clinical evidence generation and communications with stakeholders.
Co-founder & Managing Partner
Lacerta Technologies (Orthosera)
01.2009 - 05.2010
- Translated Ph.D. research into a commercially successful bone graft product (>1000 units/year).
- Authored scientific and marketing materials, developed regulatory strategy, and engaged key clinicians and partners.
Education
Ph.D. - Regenerative Medicine
Semmelweis University
Hungary01.2017
Executive MBA - Finance
Szent István University
Hungary01.2018
M.Sc. Pharmacy (Pharm.D.) - undefined
Semmelweis University
Hungary01.2008
Skills
- Clinical Evaluation
- PMCF
- Systematic Literature Review
- MDR 2017/745
- MEDDEV 27/1 Rev 4
- MDCG Guidance
- CER Gap Analysis
- Risk Management
- Regulatory Submissions
- Technical Documentation
- Scientific and Medical Writing
- Cross-functional Collaboration
- Clinical Evidence Strategy
- Audit and Compliance (ISO 13485 / FDA QSR)
Languages
Hungarian
Native or Bilingual
English
Native or Bilingual
Italian
Limited Working
Timeline
Medical Device Lead Auditor & Product Expert
TÜV Rheinland North America
02.2023 - Current
Technology Transfer Manager
University of Missouri
07.2022 - 07.2023
Regulatory and Clinical Evidence Specialist
Independent Consultant
05.2018 - 02.2023
Clinical Research Coordinator
Gedeon Richter Plc
06.2015 - 03.2016
External Auditor / Technical Documentation Assessor
European Notified Bodies
06.2013 - 07.2022
Co-founder & CEO
ITM Kft
05.2010 - 09.2015
Co-founder & Managing Partner
Lacerta Technologies (Orthosera)
01.2009 - 05.2010
Executive MBA - Finance
Szent István University
M.Sc. Pharmacy (Pharm.D.) - undefined
Semmelweis University
Ph.D. - Regenerative Medicine
Semmelweis University