Interim Manager Regulatory Affairs and QM medical devices

30 years of effective Strategic & Operative expertise in Regulatory Affairs & Quality Management for Medical Devices industry global Market Access

• CE-Kennzeichnung
• Design (allg.)
• Forschung & Entwicklung
• Klinische Forschung
• Produktionstechnik (allg.)
• Prozessvalidierung
• Qualitätsmanagement (allg.)
• Regulatory Affairs
• Technische Dokumentation
• Verpackungstechnik

At [...] Consulting, my focus is on steering innovative medical devices through the complex terrain of global regulatory affairs and quality management. With a strong grasp of the European, American, and Asian markets, my strategic and operative expertise propels medical technology from conception to widespread clinical use.

Our team’s accomplishments include successful multicenter clinical studies and securing numerous marketing approvals. Mastery in regulatory affairs, coupled with a deep understanding of class III medical devices, ensures that clients receive unparalleled guidance navigating the stringent requirements of international medical device regulations.

Get in touch for your sustainable Return on Investment.

Technical Documentation (eCTD, DHF, DMR, DHR, STED) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory tests, Software & Hardware validation (CSV, ERP), Preclinical & Clinical evaluation, Post Marketing Surveillance (PMS), Post Market Clinical Follow-up (PMCF).
Compliance to applicable Standards (e.g. ISO, IEC, EN, AAMI, MIL). GMP, GCP, GLP

Manufacturing Process Verification and Validation (DQ, IQ, OQ, PQ).

Risk Management (Risk Analysis & Risk Control) of Product & Production-process, including Additive Manufacturing (3D-printing of devices).

Clinical Evaluation, Clinical Study Organization (plan & report), Ethics Committees (IRB), including effective global multicenter Clinical Studies.

Audits & Evaluation of Production Processes & Suppliers.

Medical Device Reporting to Competent Authorities (e.g. BfArM, US-FDA).

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / Corrective Project.

On site Support during Notified Body audits (e.g. TÜV), and US-FDA inspections.

Effective management leading to a multitude of marketing approvals in the EU, Americas (e.g. US-FDA), and Asia.