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Safety - medical devices - quality assurance
Certification/surveillance of quality assurance systems in compliance with MDD (93/42/EEC):
Quality assurance and management systems are widely-used instruments for the regulation of organizational procedures between single departments of a company or between different suppliers. The system of rules developed for this purpose is known by the name "ISO 9000". Contrary to the voluntary application of such organizational principles, the Medical Device Directive (MDD) mandatorily requires that the manufacturer's quality assurance system be approved and surveilled by a notified body as a precondition for launching medical devices onto the market.
Which demands are made?
The system's minimum scope is regulated in Article 11 and described in Appendixes II to VI. It depends on the product range and can be chosen by the manufacturer. Possibilities range from an individual test according to App. IV to a final inspection according to App. VI or a test of the complete quality assurance system as per App. II.
Which scope is reasonable?
Depending on the product's risk class, the complexity of the production and the expected cycle of innovation, completely different systems may be required. To determine a reasonable scope the requirements of the harmonised standard for quality management systems (DIN EN ISO 13485) can be taken as a guide.
According to MDD, the following systems can be applied:
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complete quality assurance systems in accordance with App. II |
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QA Production (excluding design) in accordance with App. V |
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QA Product (end inspection only) in accordance with App. VI |
We find the right system for your company!
After a preliminary talk with you and an official test order, we check your documentation and prepare an audit questionnaire. This questionnaire is sent to you in advance to be filled in and sent back.
In the certification audit the implementation of the manufacturer's QA system and possible shortcomings of the documentation are discussed with regard to the medical device to be certified. The results, findings and recommendations are recorded in an audit protocol.
If it is proved that the QA system complies with the minimum requirements of the MDD and the harmonised standards respectively (possibly after the manufacturer has fulfilled certain imposed obligations ), a certificate can be issued and attached to your product file. This certificate is an essential precondition for drawing up a CE declaration of conformity and labelling your products with the CE mark.
Surveillance
By surveilling your QA system we as notified body ensure that the you as manufacturer fulfil your obligations properly. Follow-up audits are normally conducted on a yearly basis. Their scope depends on the type of quality assurance system, the company's number of employees and proof of audits by the manufacturer himself.
Costs/questionnaire
In order to answer your question about the certification costs, many factors have to be considered. The main aspects are the implementation, organization and documentation of the QM system.
To estimate the certification costs, we need detailed information about your production and corporate structure as well as the products themselves. Please, fill in our questionnaire and get a quotation.
Please, send the questionnaire and advertising material of your product to:
Prof. Dr. Dieter Millner
Fax: +49 (0) 3722
- 7323-899.
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