Experts for Medical Devices

Approval for Medical Devices – from the Medical Device conception to Post-Market Surveillance

 

The qtec services GmbH is a young, up and coming company, housing around 70+ employees. The team of tightly knit experts, is proud to identify itself as an important ally to Medical Device engineers. The service we offer, correlates directly with the typical life cycle of a Medical Device. It begins with Requirements Engineering and Risk Management, Software Quality, Verification and Validation, Clinical Evaluation, Registration, and continuing on to Post-Market Surveillance. Our team of experts are happy to support you and your company with the Medical Device Regulation (MDR).

Experts of Medical Devices

Approval for Medical Devices – from the product conception to Post-Market Surveillance

 

The qtec services GmbH is a young, up and coming company, housing around 62+ employees. The team of tightly knit experts, is proud to identify itself as an important ally to Medical Device engineers. The service we offer, correlates directly with the typical life cycle of a Medical Device. It begins with Requirements Engineering and Risk Management, Software Quality, Verification and Validation, Clinical Evaluation, Registration, and continuing on to Post-Market Surveillance. Our team of experts are happy to support you and your company with the Medical Device Regulation (MDR).

Regulatory Affairs

Approval management e.g. for Medical Devices and IVD.

Quality Management

Specific systems to ensure the quality of a Medical device

Design Control

Standardized methods accompanying the design and development of Medical Devices.

Clinical Affairs

Demonstrating clinical benefit in the practical use of Medical Devices.

qtec Spotlight season 2

In the Spotlight

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What is the Spotlight?

With the qtec Spotlight, we shine a spotlight on a current topic from the world of medical device approval for three months. Read the details here.

Clinical Evaluation of Software as a Medical Device according to MDCG 2020-1

Clinical evaluation refers to a process that must be performed as part of the quality management system in the life cycle of any medical device.

Lifecycle Management

Lifecycle management tool support in medical technology. DOORS, RQM or ELM - manage requirements, tests, documentation and traceability correctly.

References

Projects and customers worldwide

qtec group
more than120

international customers

more than3500

successfully managed projects

our customers are active in100

countries

customers with up to85

billion € annual turnover

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Accumulated expertise for advanced seminars

Our platform for aplication-oriented training is onine. With the qtec Academy, we offer our expertise to other companies. Where interactive trainings and webinars are the main focal point of these advanced classes. Find the right seminar now.

qtec Academy

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Clinical Affairs; attention to detail.

Our expertise

Optimize your statistical design of experiments

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