プロフィール詳細

プロジェクトを作成

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Ilkay K.に依頼

Germany

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

プロフィール概要

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).

専門分野

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

サービス

• 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

職務経験

Head of Regulatory Affairs

MAXCERT MDR CONSUTANCY

1月 2018 - 現在

学歴

Master of Communication in Digital Media

Universität Mannheim

1月 1996 - 1月 1999

認定資格

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

  TÜV

  1月 2010 - 現在