WÓCIK DESIGN company with design and implementation experience and competences offers services regarding the introduction of a medical device to the market and preparation for the certification of the requirements of EN ISO 13485: 2016 standard:
- preparation of technical documentation of the medical device,
- verification of technical documentation of the medical device,
- preparation of the product for testing for compliance with EN 60601-1 and EMC tests,
- commissioning tests and cooperation with external laboratories,
- conducting / authorizing tests for compliance with specific standards,
- classification of the medical device, preparation of a list of harmonized standards, preparation of a medical device compliance checklist with the essential requirements of Directive 93/42 / EEC, determination of product lifetime, preparation of a device analysis report as PEMS, preparation of product acceptance instructions, list of critical elements and declaration of conformity,
- implementation of the Quality Management System in accordance with ISO 13485: 2016 – preparation of procedures in line with the standard, – preparation of the quality book,
- test for compliance with EN 60601-1,
- EMC test.
The possession of technical documentation is the legal obligation of the manufacturer of medical devices. It must be available to the authorities at any time as proof of compliance with the Medical Devices Act. The technical documentation of the medical device includes:
- construction documentation,
- technological documentation,
- product specification (eg in the form of a company standard),
- instructions for use,
- risk analysis,
- clinical evaluation,
- reports on clinical trials,
- eports on utility ratings,
- reports on laboratory tests,
- device service instructions.
Medical Directives – 93/42 / EC, 98/79 / EC, 90/385 / EC – describe three groups of medical devices:
- generally understood medical devices – 93/42 / EC,
- in-vitro products – 98/79 / EC,
- active medical implants – 90/385 / WE,
Each medical device must be assigned to one of the above groups. The manufacturer must show that his product meets the requirements of the directive – based on the chosen conformity assessment path. We help to carry out conformity assessment by preparing evidence that the product meets the requirements of the directive.
EN-ISO 13485: 2016 standard – is dedicated to the design and / or manufacture, installation and servicing of medical devices classified in group IIa, IIb or III or class I with measuring or sterile function – product division (classification) according to Annex IX.
EN-ISO13485: 2016 standard allows to design and implement an effective quality management system, is harmonized with the requirements of medical directives, which means that based on the requirements of this standard, you can evaluate the production supervision system or the full quality assurance system of the medical device manufacturer. The standard specifies the requirements for the ability to deliver medical devices and related services to strictly meet the client’s requirements and applicable legal requirements for medical devices and related services.
This system can be supplemented with the requirements of relevant medical directives.
The implementation of EN-ISO 13485: 2016 gives:
- certainty that the devices, products and medical services delivered meet the necessary regulations in this respect,
- informs the client about the quality of supplied medical devices and accompanying services,
- reduces the possibility of improper operation of medical devices.
Registration of medical devices – in accordance with the requirements of the Act on Medical Devices, each medical device must be registered in the Register of Medical Devices kept by the Office for Registration of Medical Devices.
The WÓJCIK DESIGN company prepares the product documentation for the purposes of registration and other documents related to the application and a formal notification of the product to the Register.
According to the definition in Directive 93/43 / EEC, a medical device is: “A tool, apparatus, apparatus, equipment, material or other article used alone or in combination, including software necessary for the proper use of the device, intended by the manufacturer for human use in order to:
- diagnosis, prevention, monitoring, treatment or alleviation of diseases,
- diagnose, monitor, treat, mitigate or compensate for the effects of injuries or impairments,
- research, replacement or modification of the anatomical structure or physiological process,
- birth control,
which does not achieve its basic intended action in the body or body by pharmacological, immunological or metabolic means, but whose action can be supported by them ”
The conformity assessment procedure for Class I medical devices is significantly simplified – preparation of technical documentation in accordance with the requirements of Annex VII of the Medical Directive 93/42 / EEC is required under the sole responsibility of the Manufacturer. The participation of a notified body is not necessary, the implementation of the full ISO 13485 system and the registration of the product with the Registration Office.