Medical Certification

The technical side of health

Technology is becoming increasingly important within the framework of medical diagnostics and treatment. Accompanying it are legal requirements for their manufacture and operation. TÜV NORD CERT conducts all relevant certifications and product tests for manufacturers and operators of medical devices.

A medical device: What is it?
Medical devices are defined as instruments, machines, devices, materials or objects used in healthcare either individually or together including the software needed to ensure that they work properly.

They are used:

• To detect, prevent, monitor, treat or alleviate illnesses
• To diagnose, monitor, treat, alleviate or compensate for injuries or disabilities
• To examine, replace or change the anatomic structure or a physiological process
• Family planning

Their primary effects in or on humans is not achieved by pharmacological or immunological means nor via metabolism but can be supported by other means.

Comprehensive certification and testing
TÜV NORD CERT GmbH is a certifier for active and non-active medical products and accredited by the Central Authority of the States for Safety Technology (ZLS) and Central Authority of the States for Health Safety (ZLG).

With this complete and internationally recognized testing and certification program, we are oriented both to manufacturers as well as operators of medical devices in hospitals, clinics, doctors' offices or medical supply and rehabilitation supply stores.

We thus give you assurance of successful marketing and safe operation and ease your workload with a number of additional services such as, for example, extensive user trainings, as part of our testing and certifications.

Manufacturer

In addition to QM system certifications in accordance with DIN EN ISO 13485:2010 or DIN EN ISO 9001:2008, we also offer certifications in accordance with the annexes of EU directives (AIMDD and MDD). The proven fulfilment of the applicable EU directives is the legal prerequisite for selling medical devices in the European domestic market.

We are a certifier for active and non-active medical products and accredited by the Central Authority of the States for Safety Technology (ZLS) and Central Authority of the States for Health Safety for pharmaceuticals and medical devices (ZLG).

We certify in accordance with the following standards and directives:

• Quality management systems: e.g. ISO 9001; ISO 13485; CMDCAS (Canada); E3/833 (Greece); PAL (Japan)
• Medical products EC directive 93/42/EEC
• Actively implantable medical device: EC directive 90/385/EEC

The CE marking is used to express compliance of the devices with these directives. The conformity declaration associated with this requires, depending on the type and classification of the devices, specific safety aspects to be tested and the use of different conformity assessment procedures. Detailed information to the various conformity assessment procedure are included in our information folder.

Approval for the Canadian market will be offered within cooperation with our subsidiary company TUV USA Inc.
As a result of our cooperation with the Japanese Notified Body, Cosmos Corporation, we are also able to offer you certification in line with the Japanese "Pharmaceutical Affairs Law" (PAL).
We will pleased to make you an offer based on the questionnaire for interested parties medical and rehabilitation centres regarding the certification of QM systems and the certification of products and QM systems for medical products. If you are interested in conformity assessment procedures, please fill out our application form.

TÜV NORD CERT is also accredited by the ZLG /ZLS for product testing in accordance with Annex III and Annex IV of the medical device directive 93/42/EEC. We conduct product design tests in accordance with Annex II.4 of the medical device directive (design dossier).

Operators

The complexity of the legal regulations and technical properties of medical devices requires a special type of expertise in certification and testing that the operators themselves cannot provide on their own.

We will be pleased to make you an offer based on the questionnaire for interested parties (medical and rehabilitation centres) regarding the certification of QM systems and the certification of products and QM systems for medical products.