Berlin Cert - Testing and Certification of Medical Devices

Berlin Cert is an independent, internationally-accredited institute for the testing and certification of medical devices.

With an illustrious heritage demonstrating excellence and specialist expertise, the institute offers a complete service - from consultancy and testing, up to the certification of quality management systems for an extensive array of medical products and technologies.

Accredited testing of medical devices

In the Berlin Cert test laboratory, experienced engineers test the safety and performance-related product functions of an extensive range of active and non-active medical devices through accredited test procedures. The range of devices tested are outlined below.

Active medical device testing

• Devices for monitoring and determination of vital parameters
• Extracorporeal circulation devices, infusion and hemophoresis devices, incubators, breathing and oxygen therapy devices
• Surgical devices and surgical assist devices
• Stimulation devices
• Imaging devices with non-ionizing radiation
• Devices for hyperthermy
• Disinfection devices
• Rehabilitation and active prosthetic devices
• Patient support surfaces and movement devices
• Software for medical devices
• Medical supply units

Non-active medical device testing

• Manually propelled wheelchairs, manual attendant-controlled wheelchairs
• Shower and commode chairs, raised toilet seats
• Rollators, walking chairs and walking frames
• Prostheses for the lower limb

In addition, an increasing number of clients choose to have the concept and the design of new products tested in the 350² test laboratory. This facility combines safety testing, the assessment of the risk management plan and clinical evaluation.

Certified quality management systems

Today, there is an enormous weight of responsibility on companies that produce and circulate medical devices to meet the stringent requirements of international markets as well as the legislator. Ensuring quality is therefore essential.

Berlin Cert is expertly placed to help fulfil these requirements. The institute provides an effective quality management which is modern, tailored to the specificities of the enterprise and implemented through structured and easily comprehensible processes.

These bespoke quality management systems bring increased efficiency and reduced risks through transparent and defined processes, ensure early fault detection and avoidance and ultimately demonstrate to the customer the rigorous measures undertaken to produce devices of the highest quality.

Certification of medical products

Berlin Cert is authorized by the Zentralstelle der Länder für Sicherheitstechnik (ZLS) to certify medical products according to the Medical Device Directory 93/42/EEC.

• Devices for monitoring and determination of vital parameters
• Extracorporeal circulation devices, infusion and hemophoresis devices
• Devices for anesthesia, incubators, breathing and oxygen therapy devices (except equipment and devices for hyperbaric oxygen therapy)
• Surgical devices and surgical assist devices (except lithotripters, ultrasonic and surgical laser devices)
• Imaging devices with non-ionizing radiation (except MRT devices)
• Radiation therapy devices with non-ionizing radiation (except laser therapy devices)
• Stimulation devices
• Ophtalmology devices
• Devices for dental treatment
• Devices for rehabilitation and active protheses
• Devices for bedding and transportation of patients
• Medical supply facilities

Additional services

The philosophy of Berlin Cert is to offer its clients a complete service from consultancy and testing, up to the certification of quality management systems for a broad spectrum of medical products. Berlin Cert therefore offers additional services to its clients:

• Tests during the development stage of your products
• Consultation in risk management questions according to ISO 14971 and in the admittance of medical products
• Comparative examinations of medical devices
• Support of clinical tests
• Compatibility tests of reusable or single-use accessory parts
• Technical tests of items made to specification
• Assessment of the technical safety of devices prior to their clinical evaluation according to annex VIII

As an independent organisation, Berlin Cert is not permitted to offer their clients any support with respect to the registration of their products. On the other hand this support is needed by many customers. In particular foreign companies are often overstrained with the registration procedure required for device registering. This support is offered by BEO Berlin - a cooperation party of Berlin Cert.