EN ISO 13485 provides the guidelines for a quality management system (QMS) that is used in the entire medical device market.

The foreword to the current edition clearly emphasises this fact by not only addressing all manufacturers, but also explicitly including service providers (trade, service, installation, contract manufacturing…). In contrast to EN ISO 9001, which addresses the broadest possible user clientele, EN ISO 13485 specifically addresses companies and organisations that deal with medical devices and services in their market.

Nevertheless, ISO 13485 remains a process-orientated standard. It continues to offer an industry-orientated opportunity to align one’s own processes and regulations with the requirements of medical device legislation and thus provide evidence of systematic compliance with the rules applicable to the handling of medical devices.

Certification in accordance with this “gold standard” of the medical device market provides an objective proof that your QM system fulfils the standards applicable to your activities.

ISO 13485 is also the normative basis for the Medical Device Single Audit Programme (MDSAP) and the recognition in Taiwan as part of the Technical Cooperation Programme (TCP).

mdc is one of the few certification bodies in Europe recognised by the Taiwanese government. The proof of an established quality management system in accordance with ISO 13485 can make it considerably easier for our customers to obtain product authorisation in certain regions.

Audits within the framework of MDSAP can be carried out with our auditors via a cooperation partner recognised under MDSAP and offer the possibility of proving compliance with the regulatory requirements for QM systems of up to five participating countries in the course of a certification procedure: Australia, Brazil, Japan, Canada and the USA. This also can significantly simplify product authorisation in the countries covered.

We have been auditing and certifying QM systems on the basis of standards since 1994 and in 2022 we were accredited by the German Accreditation Body (DAkkS) for the latest edition of DIN EN ISO 13485. This accreditation allows us to offer our customers recognised certification in accordance with EN ISO 13485:2016 with its supplements and DIN EN ISO 13485:2021 in our function as a certifier in the field of medical devices and in-vitro diagnostics.

In line with our motto “Out of responsibility for safety and quality”, we are your point of contact with our broad expertise and comprehensive industry knowledge of the medical device sector. Our offer is aimed at you as a:

• Manufacturers of medical devices and in-vitro diagnostics (series production)

• Manufacturers of medical devices (customised products)

• Suppliers, subcontractors and service providers

• Service organisations

• Distributors, importers, authorized representatives

Special procedures for third countries, such as MDSAP or TCP, can also be combined with certification in accordance with ISO 13485, which is their basic standard.

A quality management system (QMS) is required to place medical devices on the market, the effectiveness and safety of which must be guaranteed for patients and users. Companies and organisations certified to EN ISO 13485 by mdc can thus prove that their QM system is capable of fulfilling the legal requirements of the MDR and IVDR for a QM system.
The EN ISO 13485 standard, which enjoys global recognition, contains detailed requirements for a QM system for companies involved in the provision of medical devices. This includes not only manufacturers (series products or customised products) but also others involved in the life cycle of a medical device. In addition to distributors and importers, this also includes service providers such as contract manufacturers or service companies. For contract manufacturers in particular, ISO 13485 is a prerequisite for opening up national and international markets in Europe and worldwide.

In addition to compliance with regulatory, i.e. legal and normative requirements for products, ISO 13485 also focuses on risk management, which aims to identify and minimise risks at an early stage.

This creates confidence in the safety and quality of products and increases satisfaction and customer loyalty.