Partner for Medical Device manufacturers

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 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).

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.

References

Projects and customers worldwide

more than120

international customers

more than3500

successfully managed projects

our customers are active in100

countries

customers with up to85

billion € annual turnover

Technical Documentation for Medical Devices

Keeping the documentation of the development process, the design and manufacturing of the medical device up to date can bear many challenges. Are you keeping an eye on your Technical Documentation? The qtec Aktenfuchs will keep your documentation adequate and organized.

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News

Body Modification and the MDR
22. December 2021 0
Very few manufacturers and artists are aware that some of these products fall under the new Medical Device Regulation EU 2017/745 (MDR).

Impact of the MDR on Quality Assurance Agreements (QAA)
28. October 2021
We will show you why a quality assurance agreement is an important and central document of the MDR, and should make sure it is always up to date.
Regulatory Affairs Update 42/21
20. October 2021 0
Areas: Europe, USA, Australia / Updates, New regulations and guidances 42/21
Regulatory Affairs Update 40/21
6. October 2021 0
Areas: USA, Australia, Singapore, India / Updates, New regulations and guidances 40/21