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Certification

Medical Devices

A medical device: What is it?

According to the definition enclosed in Directive 93/42/EEC, 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.

As Polish Notified Body No. 2274, TÜV NORD Polska conducts relevant certifications for manufacturers and operators of medical devices. We specialize in active and non active medical devices, sterile devices, electrical medical equipment and software. Our auditors conduct audits and provide certification procedures according to 93/42/EEC.

 

Quality Management System Certification

ISO 13485, ISO 9001

 

TÜV NORD POLSKA offers certification of the quality management system according to ISO 13485 and ISO 9001.

 

ISO 13485 represents the requirements for a comprehensive management system for the design and manufacture of medical devices. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained. Other specific differences include:

  • the promotion and awareness of regulatory requirements as a management responsibility

  • controls in the work environment to ensure product safety

  • focus on risk management activities and design control activities during product development

  • specific requirements for inspection and traceability for implantable devices

  • specific requirements for documentation and validation of processes for sterile medical devices

  • specific requirements for verification of the effectiveness of corrective and preventive actions

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of e.g. Medical Devices 93/42/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE marking and the permission to sell the medical device in the European Union.

We offer our services worldwide exept the territory of USA and Canada.

 

If you have any questions or would like to cooperate with TÜV NORD Polska, contact us:

 

Małgorzata Chynowska

Product Manager of Medical Devices Certification

TÜV NORD Polska Sp. z o.o.

m.chynowska@tuv-nord.pl


mobile: +48 601 552 498

tel. +48 (22) 276 37 97


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Kontakt

Małgorzata Chynowska Product Manager +48 22 276 37 97 +48 601 552 498 Tel. komórkowy m.chynowska tuv-nord.pl
Kornel Lukaszczyk Kierownik Jednostki Notyfikowanej nr 2274 +48 32 786 46 45 +48 693 620 824 Tel. komórkowy k.lukaszczyk