プロフィール詳細

プロジェクトを作成

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Oliver S.に依頼

Switzerland

Medical Device Regulatory Advisor & Compliance Reviewer (MDR / FDA / ISO)

プロフィール概要

As a former Post-Market Surveillance & Vigilance Manager at Mathys (Swiss manufacturer of artificial joint implants), I have extensive hands-on experience in EU MDR compliance. I successfully created and maintained multiple PMS Plans, Periodic Safety Update Reports (PSURs), and other technical documentations that passed TÜV SÜD inspections and achieved full MDR certification for Class I–III devices. This includes updating legacy MDD documentations to meet MDR requirements, ensuring smooth transitions for established products. I can also provide targeted advisory and compliance review support for FDA 510(k) submissions and related documentation. With a Bachelor's in Medical Engineering, in-depth knowledge of anatomy and medicine, and Certified Professional status in Requirements Engineering (Foundation Level), I specialize in regulatory documentation, post-market surveillance, vigilance reporting, risk management (ISO 14971: application of risk management to medical devices, covering hazard identification, risk evaluation, control, and lifecycle monitoring), and quality management systems (ISO 13485: requirements for QMS in design, development, production, and regulatory compliance of medical devices). I maintain a comprehensive personal library of key norms — including MDR xxxxxxxx (DE/EN), ISO 13485 (commented), ISO 14971, IEC xxxxxxxxxxx, FDA Design Controls, and more — plus anonymized production templates from my prior work experience for rapid, accurate adaptations. I help medical device companies (especially startups and SMEs) meet MDR/IVDR obligations efficiently: customizing PMS/PSUR templates, conducting regulatory gap assessments, reviewing vigilance data, updating technical files, or providing targeted advisory support. My approach delivers compliant, high-quality results quickly — often in 1–2 days for document adaptations — reducing compliance risks and accelerating market readiness. Fluent (C2 level) in English, with native proficiency in German and Finnish, I offer reliable, detail-oriented support for one-off projects or ongoing needs. Open to part-time retainers after successful collaboration. Let's discuss how I can support your regulatory projects.

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ ISO 13485
• ★ ISO 14971
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing General Proofreading & Editing

Research Fact Checking, Gap Analysis, Systematic Literature Review

Consulting Go-to-Market Strategy Consulting, Healthcare Consulting, Legal Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Product Evaluation, Product Validation, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development

職務経験

Post Market Suverllance & Vigilance Manager

Mathys Medical AG & Enovis International

5月 2022 - 12月 2023

学歴

Medical Engineering

HSLU - Lucerne University of Applied Sciences and Arts - Switzerland

9月 2017 - 2月 2022

認定資格

• Certified Professional for Requirements Engineering

  Certible (by IREB International Requirements Engineering Board)

  https://www.certible.com/verify/d5f3b8fa857b701ca085d3eec881282c/

  2月 2019 - 現在