Claudia Brakop

Claudia Brakop is a regulatory and quality assurance specialist with more than 20 years’ professional experience in the healthcare, medical devices and pharmaceutical sectors. Her core expertise encompasses regulatory affairs, quality management, audit, risk management, clinical evaluation, qualification and validation.

Since 2022, Claudia has led an expert group advising clients on the implementation and maintenance of quality management systems and the preparation of technical documentation for medical devices (MD) and in vitro diagnostics (IVD) across all risk classes.

• More than 10 years’ experience with Good Manufacturing Practice (GMP) in the pharmaceutical sector
• Internal and Lead Auditor (Lead Auditor ISO 13485:2016) with over 18 years’ auditing experience
• 20+ years’ experience in preparing technical documentation for market approval
• 5+ years as Person Responsible for Regulatory Compliance (PRRC) according to MDR (EU) Article 15.