ISO 13485ISO 13485 Quality management system for medical device in Malaysia

ISO 13485:2016 Quality Management System for Medical Device Certification

Efficient medical device quality management system and testing

Efficient medical device quality management system

Certify your quality management system for medical devices with ISO 13485

Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons. For these reason, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system. Medical devices manufactured or supplied by organisations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities.

What is ISO 13485?

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. Originally developed in the 1990s, the standard details requirements for a quality management system that meets both customer requirements and regulations in the European Union (EU), Canada and other major jurisdictions around the world. ISO 13485 is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485.

The significance and efficacy of this standard has led several countries to harmonize their local accreditation frameworks with ISO 13485. SAC ISO 13485 is a local accreditation scheme in Singapore, administered by the Singapore Accreditation Council (SAC), designed to ensure that Singapore medical device manufacturers adhere strictly to safety and quality norms in their management practices. TÜV SÜD is an accredited certification body (CB) by SAC to facilitate the certification of companies to SAC ISO 13485. 

Why is it important?

In the EU, the requirements of EN ISO 13485 have been harmonised with the essential requirements of the EU’s Medical Device Regulation and In-Vitro Diagnostic Medical Device Regulation. Certification to EN ISO 13485 by an accredited certification body provides a presumption of conformity with the General Safety and Performance Requirements of these important regulations. In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR). Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485. In Singapore, manufacturers, importers and wholesale suppliers of medical devices are required to comply with the updated SAC ISO 13485 accreditation program by 1 January 2025. 

How can we help you?

TÜV SÜD is one of the largest organisations providing certification services under the EU MDR and IVDR, and our technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices. In addition, we are one of leading global management certification body for quality management systems, including management systems applicable in the manufacture of medical devices. Each audit team consists of experts with the skills and expertise needed to accurately assess the compliance of your management system. This combined experience makes TÜV SÜD ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485 certification.

Why choose TÜV SÜD

TÜV SÜD offers solutions to test and certify for the safety and performance of medical devices. Our global network of more than 750 dedicated medical health and services professionals include noted scientists and physicians in their respective fields. These capabilities make TÜV SÜD the preferred single source for worldwide compliance with medical device regulations. 

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