ISO 13485/MDD
Overview
ISO 13485 is a quality standard for organisations that design, develop, produce or service medical devices. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. It includes specific requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate to the medical device industry. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation.
ISO 134585/Medical Device Directive Certification
Doctors and medical professionals use sophisticated medical devices on an everyday basis. ISO 13485 is a single standard for all classes of medical devices and its scope includes design and manufacture. It is a key regulatory consideration for allowing medical device manufacturers to market their products around the globe.
Manufacturers of high-risk medical products must be associated with a notified body to vouch for the product's quality. This is achieved through product testing and auditing of the manufacturer's quality management system.
PT. TÜV NORD Indonesia is a notified body for all medical products. It certifies products and QM systems for the European market as well as for non-European countries.
Benefits of adoption:
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Demonstrates the manufacturer's ability to supply medical devices and related services that are compliant with all regulatory requirements
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Adoption of this standard assures the customers that the product complies with all relevant product and service-oriented technical standards and regulations
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Cleanliness and sterility in the production area increases efficiency and enhances safety at the workplace
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Certification process
The certification process is a multiple-step process. The certification cycle is described briefly:
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Application for certification from client
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Offer from PT. TÜV NORD Indonesia
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Offer acceptance from client and order confirmation by PT. TÜV NORD Indonesia
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Preaudit (optional)
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Certification audit
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Issue of certificate on successful completion of certification audit
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Surveillance audits at defined interval
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Recertification audit
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TUV's services
In an age when medical advances are characterised by state-of-the-art equipment, the ISO 13485/13488 standard has gained much importance. The standard pertains to the business processes concerning critical medical equipment manufacture, testing, compatibility, endurance, installations and delivery. PT. TÜV NORD Indonesia and TÜV Nord Group are renowned for their specialised audit pool for ISO 13485/ 13488 certifications.