DQS Medical Devices

Since May 26, 2021, the Medical Device Regulation (EU) 2017/745 has replaced the MDD (Medical Device Directive 93/42/EEC) and AIMDD (Active Implantable Medical Devices Directive 90/385/EEC ), setting rigorous standards and conformity assessment procedures for medical device companies in the European Economic Area (EEA) to ensure patient safety and product efficacy.

ISO 13485 outlines quality management system requirements for organizations involved in the medical device life cycle, such as design, production, distribution, installation, or servicing of medical devices, as well as associated activities like technical support, improving efficiency, reducing costs and risks, and enhancing customer satisfaction.

The Medical Device Single Audit Program (MDSAP) enables medical device manufacturers to qualify for multiple markets with a single audit: Australia, Brazil, Japan, Canada, and the USA. The benefits of the program extend beyond the recognition of results for medical device registration, including the reduction of on-site inspections by participating authorities and related costs.

The Technical Cooperation Programme (TCP III) provides EU-based companies with the opportunity to market medical devices in Taiwan without requiring an additional audit by a TFDA-recognized auditing body. DQS is recognized under the Technical Cooperation Program (TCP III), and with your quality management certified by us, obtaining product approval in Taiwan becomes easier and faster.

ISO 15378 applies to manufacturers of primary packaging materials that come into direct contact with pharmaceutical products. The standard covers all common materials used for primary packaging. All contract manufacturers of these materials or manufacturers who package pharmaceutical products themselves can ensure early compliance with high GMP standards and international acceptance with ISO 15378.

• Recognized expertise in medical devices for more than 20 years
• Active participation in standards and technical committees
• Broad product portfolio of various normative and legal certification programs from one source
• Worldwide network with over 200 experienced assessors and expert
• Global resource with focus on customer relationship through dedicated Regulatory Affairs Managers