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Inspection and Supervision Services for Medical Devices

Medical Devices

Manufacturers of medical devices are held to an extremely high standard. Regulatory bodies, hospitals, health care practitioners and patients expect the devices used to treat and heal illnesses and injuries to be safe and to perform as promised. The stakes are high in this sector, and the level of technology unmatched. It takes teamwork to succeed in this market, to be competitive, to establish a reputation for reliability and to stay abreast of new scientific and regulatory developments. We are valuable team players with the skills, stamina and specialized services necessary to assist you in producing and operating the most effective, technologically sophisticated and safest products for the medical sector. Benefit from our comprehensive services, fast lead times and our long-standing experience in the field of medical devices.

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

Medical Devices

Team player for your medical products and in vitro diagnostics.

Active Implantable Medical Devices
Active Implantable Medical Devices  

Special scrutiny regarding safety, functionality and durability of active medical implants.

Active Medical Devices
Active Medical Devices  

Enabling compliance and high safety standards for active medical equipment.

In-Vitro Diagnostics
In-Vitro Diagnostic Devices  

Ensuring the reliability and safety of your IVD medical devices.

Non-Active Medical Devices
Non-Active Medical Devices  

A reliable partner for compliance, performance and safety of non-active medical equipment.

Contact

Get in contact with us!

Get in contact with us!