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Inspection and Supervision Services for Active Medical Devices


Active Medical Devices

So much of today’s medical landscape, including diagnostics and all levels of treatment, rely on active medical devices. Active MDD cover all devices requiring a power source other than the body itself or gravity. Lives and health depend on the safe and accurate functioning of such instruments, and your company is dedicated to providing doctors, hospitals and paramedics with life-saving tools of the highest standard. In addition to maintaining a high level of performance internally, this means complying with external directives and regulations set forth by national and international authorities. Well-versed in the intricacies of medical device compliance worldwide, our experts offer services designed to meet your needs. Our laboratories, located across the globe, are among the most sophisticated in the world, and we provide the expertise to match.

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 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.

Manufacturer's Service for Medical Devices
Manufacturer's Service for Medical Devices 

Ensuring quality and safety of medical devices from approval through market launch to disposal.

Medical and X-Ray Device Management
Medical and X-Ray Device Management 

Management Support for Your Medical and X-ray Equipment.

Medical and X-Ray Technology: Assessments
Assessments for Medical and X-Ray Technology  

A New Approach to Corporate Values.

Medical Device (tested)
Tested Medical Device 

Market Your Products More Effectively with Voluntary Certification.

Medical Devices: In-House Production - System Check
In-House Production of Medical Devices 

Risk Assessment for In-House Device Production and Combination.

Medical Products (MDD)
Medical Products (MDD)  

TÜV Rheinland offers a wide range of testing and certification services for Medical Devices

Medical Technology: Documentation
Medical Technology Documentation 

Specialized Inventory of Medical Devices and Equipment.

Medical Technology: Metrological Testing (MT)
Metrological Testing of Medical Equipment 

Calibrating and Verifying Your Medical Equipment.

Medical Technology: Technical Safety Controls
Technical Safety Controls for Medical Technology 

Detect Device Malfunctions on Time.

Smart Grid Product Testing
Smart Grid Product Testing  

Ensure Your Products Work in the Smart Grid.

X-Ray Equipment Audit
X-Ray Equipment Audit 

Recurrent Homologation Audits of X-Ray Equipment.

Contact

Get in contact with us!

Get in contact with us!