Carsten
★★★★★
4.9
/ 5
•
37 reviews
Carsten is a Quality Manager and international Regulatory Affairs professional with over 20 years of experience in the medical device industry. They provide PRRC support, MDR/IVDR compliance, and quality management expertise.
Carsten is a Quality Manager and international Regulatory Affairs professional with over 20 years of experience in the medical device industry. They possess a strong background as a precision engineer and industrial master craftsman.
Their expertise spans Quality Management (ISO 13485, ISO 9001, IATF 16949, TQM), international Regulatory Affairs (MDD, MDR CE marking), Risk Management (ISO 14971), Electrical Safety (IEC 60601), and Clinical Evaluation (ISO 14155). They have experience with global regulatory requirements including US-FDA (21 CFR Part 820), MDSAP, JGMP, Russia, and Ukraine, and have accompanied audits from international authorities such as FDA and Brazilian Anvisa.
Carsten has over 10 years of technical experience in medical device development, manufacturing, and documentation across all risk classes, and 10 years as a lecturer for regulatory affairs at FH-Furtwangen/Campus Tuttlingen.
About
**Who they are**
Carsten is a Quality Manager and international Regulatory Affairs professional with over 20 years of experience in the medical device industry. They possess a strong background as a precision engineer and industrial master craftsman.
**Expertise & scope**
* Quality Management (ISO 13485, ISO 9001, IATF 16949, TQM)
* International Regulatory Affairs (MDD, MDR CE marking)
* Risk Management (ISO 14971)
* Electrical Safety (IEC 60601)
* Cleaning and Sterilization (ISO 17664)
* Clinical Evaluation (ISO 14155)
* Clean Rooms (ISO 14644, GMP, VDI 2083)
* Experience with global regulatory requirements including US-FDA (21 CFR Part 820), MDSAP, JGMP, Russia, and Ukraine.
* Audits of international customers and authorities such as FDA and Brazilian Anvisa.
**Reputation / proof points**
* Over 20 years of experience in Quality Management.
* Over 10 years of technical experience in medical device development, manufacturing, and documentation across all risk classes.
* 10 years of experience as a Lector for regulatory affairs at FH-Furtwangen/Campus Tuttlingen (2014-2025).
* References include well-known companies like KARL STORZ Endoskope, KLS MARTIN Group, Olympus, and Stryker Medical.
Carsten is a Quality Manager and international Regulatory Affairs professional with over 20 years of experience in the medical device industry. They possess a strong background as a precision engineer and industrial master craftsman.
**Expertise & scope**
* Quality Management (ISO 13485, ISO 9001, IATF 16949, TQM)
* International Regulatory Affairs (MDD, MDR CE marking)
* Risk Management (ISO 14971)
* Electrical Safety (IEC 60601)
* Cleaning and Sterilization (ISO 17664)
* Clinical Evaluation (ISO 14155)
* Clean Rooms (ISO 14644, GMP, VDI 2083)
* Experience with global regulatory requirements including US-FDA (21 CFR Part 820), MDSAP, JGMP, Russia, and Ukraine.
* Audits of international customers and authorities such as FDA and Brazilian Anvisa.
**Reputation / proof points**
* Over 20 years of experience in Quality Management.
* Over 10 years of technical experience in medical device development, manufacturing, and documentation across all risk classes.
* 10 years of experience as a Lector for regulatory affairs at FH-Furtwangen/Campus Tuttlingen (2014-2025).
* References include well-known companies like KARL STORZ Endoskope, KLS MARTIN Group, Olympus, and Stryker Medical.
Additional information
This provider has extensive experience in implementing international regulatory requirements with a focus on economic efficiency. They have successfully accompanied audits from various international authorities. Their expertise spans multiple standards crucial for medical device development, manufacturing, and quality assurance, making them a valuable resource for companies navigating complex global regulations.
Key Highlights
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Over 20 years of experience in Quality Management and Regulatory Affairs within the medical device sector.
Source
“More than 20 years of experience in the area of Quality Management and in dealing with the international regulative requirements.”
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10 years of experience as a part-time lecturer for regulatory affairs (MDD/MDR-CE).
Source
“10 years (2014-2025) experience as a Lector for regulatory affairs (MDD-, MDR-CE) at FH- Furtwangen/Campus Tuttlingen”
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Proficient in implementing international regulatory requirements including US-FDA, MDSAP, and MDR 2017/745.
Source
“The implementation of the international regulative requirements as for example part CFR21 Part 820 (US-FDA), MDSAP, JGMP, Russia, Ukraine, MDR 2017/745, ISO13485:2016 were always reached with the background of the economic efficiency.”
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Experience in successfully managing audits by international authorities like the FDA and Brazilian Anvisa.
Source
“Audits of international customers and authorities as for example of the FDA and the Brazilian Anvisa were always accompanied successfully.”
Certifications & Trust Signals
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Extensive experience with key medical device standards including ISO 13485, ISO 9001, and ISO 14971.
Source
“A long standing Director Quality Manager-experiences is formed in the contact at least with the following standards and requirements: ISO 13485 Quality Management Medical Business (&MDSAP) ISO 9001 IATF 16949 Quality Management Industrial Business (IATF16949; TQM) ISO 14971 Risk-Management”
Buyer Snapshot
Best for
- Medical device manufacturers seeking PRRC support.
- Companies needing assistance with MDR/IVDR compliance.
- Organizations requiring expertise in quality management systems.
How engagement typically works
- Direct consultation and support.
- Audit preparation and accompaniment.
- Regulatory strategy development.
Typical deliverables
- Quality Management System implementation and maintenance.
- Regulatory submissions and documentation support.
- Audit readiness and execution.
- Risk management file development.
Good to know
- Best when requiring deep expertise in medical device regulations and quality systems.
HQ:
Boulder, USA
Languages:
English
Timezones:
MST
Claim status:
Claimed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Named PRRC:
Yes
Additional prrc_service Details
Device Classes Supported
All risk classes
Supports MDR
Yes
Supports IVDR
No
PRRC Qualification Summary
Quality Manager EOQ, IHK (DGQ) and Manager international Regulatory Affairs with a manufacturing background (precision engineer plus industrial master craftsman diploma). Over 20 years of experience in Quality Management and international regulatory requirements. Over 10 years of technical experience in medical device development, manufacturing, and documentation.
Regulatory Experience
Over 20 years in Quality Management and international regulatory affairs. Over 10 years in medical device development, manufacturing, and documentation. 10 years as a Lector for regulatory affairs (MDD-, MDR-CE).
