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Certification and Auditing Services for Active Implantable Medical Devices


Active Implantable Medical Devices

Current medical technology is capable of delivering healing solutions via active implantable medical devices (AIMD). These products work inside the patient’s body to calibrate and regulate physical functions, improve quality of life and extend life spans. Because they are designed to essentially become part of an individual’s body, AIMDs are subject to special scrutiny regarding safety, functionality and durability. As a manufacturer of implantable medical devices, it is your priority to stand up to this scrutiny and even exceed expectations when possible. With experts by your side with specialized knowledge of this technologically sophisticated field, your chances for success rise substantially. Our services for AIMDs address your goals and concerns, enabling you to consistently demonstrate compliance and build a strong record for safety and reliability in your sector

Unannounced audits

Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.

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New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf New MDR 1 MB Download
pdf Information according to the new European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) 290 KB Download

Our portfolio

Approvals for Greater China
Approvals for Greater China 

Let us help you with product approvals for China, Taiwan, and Hong Kong.

CB Procedure
CB Scheme 

Safety testing and CB certification for electrical and electronic components and products.

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

ISO 14001 Certification
ISO 14001 Certification for the Environmental Management System 

Have your environmental management system certified by TÜV Rheinland in accordance with ISO 14001.

Contact

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Get in contact with us!