Medical Device Regulatory & Quality Solutions

Experienced Regulatory and Quality project manager with valuable connections to Notified Bodies and Agencies.
My knowledge and skills are support to Manufacturers of Medical Devices with specialization in supporting Distribution Chain outside and inside EU under the scope of MDR 2017/745 and IVDR 2017/746 including knowledge and skills of Medical Device QMS 13485:2016.

Regulatory Consulting
• Project management and SMEs for workstreams
• Preparation of worldwide regulatory strategy and outsourcing for PRRC (person responsible for regulatory compliance)
• Medical Device new classification evaluation to MDR
• building Intended purpose, Technical files, EC mark, DoC
• EU entrance support for MDR & IVDR
• Rest-of-world support
• Labeling

Quality Systems Consulting
• Quality system development: ISO 13485, EU MDR (including ISO 14971)
• Quality system improvements
• Internal auditing
• Inspection readiness (mock auditing) and support

Post-Market Surveillance and Post Marketing Clinical Follow-up Consulting
• PMS and PMCF Plans for Medical Devices
• Complaint handling and MDR submissions
• Recall strategy and execution
• CAPA leadership and execution

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