We are a certification company and notified body with over 20 years of experience in leveraging quality within the medical devices industry—personalized, agile, and global.

Our accredited certifications enable players in the medical device industry to expand into new markets and elevate the value of their products, processes, and quality management systems. From startups to international industry giants, we provide our clients a single point of contact for all certification needs, simplifying processes and ensuring seamless compliance. Supported by our global team of experts, we help you navigate the regulatory landscape, unlocking the full potential of your products.

Discover more about our medical device certifications: CE Marking (MDR), MDSAP (Medical Device Single Audit Program), ISO 13485, ISO 15378, TCP III, and more.

MDSAP

One Audit, Five Markets

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.

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How to access the Japanese market with medical devices (for overseas companies)

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Change of certifier and/or notified body

ISO 15378

Primary Packaging Materials for Medicinal Products

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, such as glass, rubber, aluminum, and plastics. 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. For suppliers of primary packaging materials for pharmaceutical products, the standard includes all relevant GMP requirements and enables compliance with international, European, and national legal guidelines.

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Change of certifier and/or notified body

MDR (EU) 2017/745

Certification for Medical Devices in the EU Market

As of May 26, 2021, the Medical Device Regulation (MDR) (EU) 2017/745 has heralded a new era for medical device companies operating within the European Economic Area (EEA). This regulation has replaced both the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). With an unwavering focus on patient safety and product efficacy, the MDR establishes rigorous standards and conformity assessment procedures that companies must adhere to before bringing their devices to market in the EEA. Discover what requirements you need to access the European market by clicking below.

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MED unannounced audits

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Change of certifier and/or notified body

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CE marking: Notes on handling unannounced audits

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Price list of standard fees for the MDR

ISO 13485

The standard for reliable medical solutions

The ISO 13485 standard outlines the requirements for a quality management system necessary for organizations to supply medical devices and/or related services. These organizations may be involved in various stages of the product life cycle, such as design, production, distribution, installation, or servicing of medical devices, as well as associated activities like technical support. The main benefits for the companies include identifying areas for optimization in your quality management system, leading to cost savings, risk reduction, and increased customer satisfaction.

TCP III

Gain market access in Taiwan

Medical device manufacturers who want to sell their products in Taiwan must meet the requirements of the Taiwan Food and Drug Administration (TFDA). 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.

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How to access the Japanese market with medical devices (for overseas companies)