Partner for the Healthcare Industry

Experts for Medical Devices

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

The qtec Services GmbH is currently a team of over 85 smart and closely networked experts who see themselves as partners for manufacturers of medical devices. 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 is 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 currently a team of over 85 smart and closely networked experts who see themselves as partners for manufacturers of medical devices. 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 is 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.

Discover TrendReport now!

qtec TrendReport - reporting of trends according to Art. 88 as a full service for manufacturers of medical devices. We ensure the comfortable reporting of trends.

To the service

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

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 Training Brochure

News

Regulatory Affairs Update 25/23
20. June 2023 0
Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23

Regulatory Affairs Update 15/23
13. April 2023 0
Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
Post-Market Surveillance in China
4. April 2023 0
In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
Regulatory Affairs Update 05/23
31. January 2023 0
Areas: Europe, Worldwide / Updates, New regulations and guidances 05/23