
Characterized by a trustworthy and reliable nature, goal-oriented approach, flexibility in problem-solving, and professional competence.

About me
Mustafa Dinc, born in 1973 in Freising, Bavaria, has accumulated 24 years of quality management experience, eight years dedicated to the automotive industry, and 16 years in medical technology. Additionally, he has approximately eight years of expertise in the registration of medical products (e.g., CE, FDA, CFDA).
Since 2009, he has specialized in quality and regulatory management within the medical technology sector, devising sophisticated and practical solutions tailored to companies of various sizes. He has extensive project experience spanning automotive, mechanical engineering, and medical technology domains, covering active and passive medical devices ranging from Class I to III.
Key focuses in his recent projects include process validation, quality, and risk management (compliant with DIN EN ISO 14971, 13485, and 9001, MDD, MDR 2017/745, MDSAP), remediation, NC-remediation, complaint management, audit execution, process enhancement, and regulatory affairs (Class I-III), including clinical affairs.
Through his latest project, which involved implementing and executing Post-Market Surveillance as per MDR (Medical Device Regulation) Articles 83 to 92, Article 10, Article 15, and Article 61 (Clinical Evaluation Report), he has acquired profound practical knowledge in implementing MDR, ISO 13485:2016, and MDSAP, which he has been able to impart to others.
Mustafa Dinc completed his MBA in Compliance and Risk Management with the submission of his Master's thesis on the topic: 'The German Supply Chain Due Diligence Act (LkSG) – Impacts and Recommendations for Action' in mid-March 2025. The evaluation of the thesis is still pending.


My ACHIEVEMENTS
portfolio
I am pleased to offer you the following services:
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Structure and implementation of post-market surveillance according to Medical Device Regulation (2017/745) Articles 83-92 (process, plan, report, PSUR, vigilance, trending, and trending reporting, FSCA), Appendix II, Appendix III.
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Conversion of existing post-market surveillance processes according to MDD 93/42/EEC to MDR (2017/745).
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Clinical Evaluation Report according to MEDDEV 2.7.1 Rev.4 and MDR (2017/745) Article 61.
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Post Market Clinical Follow-Up (PMCF) for medical devices according to MEDDEV 2.12-2.
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Vigilance according to MEDDEV 2.12-1.
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Change management.
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NC, NCR, and CAPA management.
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Complaint handling, field corrective actions.
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Technical documentation file according to MDD 93/42/EEC then according to MDR.
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Development and implementation of the quality management system according to ISO 13485:2016.
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Creation of process instructions (SOPs, guidelines, work instructions), GMP, GDP.
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Creation and/or revision of quality management manual.
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Labeling/UDI.
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Quality management officer (QMB-BdoL) considering MDR Articles 10 and 15.
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Safety officer for medical devices.
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Preparation of laboratory tests according to IEC 60601-1 3rd edition and 3.1 edition for active medical devices.
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Verification and validation.
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Preparation for FDA audit according to CFR 21 Part 820 (Medical Devices).
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Medical device reporting according to CFR 21 Part 803.
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Preparation for MDSAP audit.
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Approval and product launches of medical devices according to MDR (Appendices I, II, IV, V).
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510(k) Medical Device Approval and Launches.
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Technical File and DHF Remediation.
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Risk management according to ISO 14971:2019.
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General project management.
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Advice on software quality projects related to cybersecurity.

"If we do all the things that we are capable of, we would literally amaze ourselves."
Thomas Edison