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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

Active Implantable Medical Devices (AIMD)
Active Implantable Medical Devices (AIMD)  

Conformity Assessments for Your Active Implants.

Active und Non-Active Medical Devices
Active and Non-Active Medical Devices 

Active and Non-Active Medical Devices.

Approvals for Greater China
CCC, NAL, CEL Approvals for Greater China 

We provide comprehensive approval and certification services for fast entry to Greater China market.

EN ISO 13485 Certification
Certification According to EN ISO 13485 

Validating Your Quality Management System.

Contact

Get in contact with us!

Get in contact with us!