The well-being of patients is our top priority. It satisfies us that, with our help, your products will be provided to the patients safely, effectively and on time.

One of our goals is to be the most qualified and flexible partner alongside manufacturers of medical devices and IVDs.



We are experts and are happy to accompany you individually in
- Quality management (audits, QM systems)
- Design control (clinical evaluations, requirements, risk, VV, PMS, ...)
- Regulatory Affairs (international approvals)

Health Care

Life Sciences

Medical Devices

qtec services GmbH

qtec services GmbH's headquarters in Lübeck, Germany

Jan Graf

Dr. med. habil. René Bombien

Petra Petermann

Anna Dinkelmeier

Andreas Genßler

Oliver V. Ruepprecht

Jan Fiedler

Jochen Harmuth

Torsten Hertz

Andreas Jaensch

Timo Bohnhoff

Juliane Celik

Kerstin Heitmann

Dr. Klaus Pollmeier

Christian Wolf

Carola Janeck

Delvyn Heinsch

Michael Imhoff

The Quality and Regulatory Affairs team at qtec services GmbH ensures that medical devices and IVDs meet stringent quality standards and regulatory requirements. They are responsible for quality management (including audits and QM systems), design control (covering clinical evaluations, requirements, risk management, validation, verification, and post-market surveillance), and obtaining international regulatory approvals. Their primary goal is to deliver safe, effective, and timely products to patients, staying flexible and qualified as a reliable partner to medical device manufacturers.

Quality and Regulatory Affairs

This department ensures compliance with quality standards and regulatory requirements in product development and management.

Quality Assurance and Regulatory

The Clinical Affairs Team at qtec services GmbH ensures that medical devices and in vitro diagnostics (IVDs) are safe, effective, and comply with all regulatory requirements. The team manages clinical evaluations, develops clinical investigation plans, and oversees post-market surveillance activities. They also produce comprehensive medical documentation and provide expert guidance on clinical aspects to support regulatory submissions and market approvals.

Clinical Affairs Team

This department ensures the quality and reliability of products through rigorous testing and validation processes.

Quality Assurance

This department oversees the management and development of clinical programs and medical strategies.

Clinical Affairs

This department oversees clinical evaluations and ensures compliance with regulatory standards.

qtec services GmbH

Org chart

Teams

Quality and Regulatory Affairs

Quality Assurance and Regulatory

Clinical Affairs Team

Quality Assurance

Clinical Affairs

Clinical and Regulatory Affairs

Offices

qtec services GmbH

Org chart

Teams

Quality and Regulatory Affairs

Quality Assurance and Regulatory

Clinical Affairs Team

Quality Assurance

Clinical Affairs

Clinical and Regulatory Affairs

Offices

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