Profile Details

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Hire Ilkay K.

Germany

USD 50 /hr

EU MDR Specialist with years of QMS experience working with companies like Tüv and Dekra as Lead Auditor

Profile Summary

20+ years of QMS experience, ISO 9001 Lead Auditor, ISO 14001, ISO 13485. Heading currently a team of MDR consultant in Germany and providing MDR trainings, documentation and consultation support interantionally. Preparation, compilation, and submission of regulatory applications for product approvals domestically and internationally. (FDA’s medical device regulations, EU MDD and MDR, UKCA, ISO standards).

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ☆ Post-Market Surveillance
• ☆ ISO 13485
• ☆ ISO 14971

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Big Data Analytics

Product Development Product Evaluation

Work Experience

Head of Regulatory Affairs

MAXCERT MDR CONSUTANCY

January 2018 - Present

Education

Master of Communication in Digital Media

Universität Mannheim

January 1996 - January 1999

Certifications

• ISO 9001 / ISO 13485 / ISO 10002/ ISO xxxxxxxxxxxxx /xxxxxxxxxxxxx / HACP-GMP

  TÜV

  January 2010 - Present