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MEDICAL STANDARDS
├ Medical supplies
※ ISO 13485 Medical devices
The importance of technology in medical diagnosis and treatment is increasing day by day. As a result, the legal requirements for manufacturers and operators of medical devices are constantly changing.
With our well-known testing and certification program, we offer maximum security for the safe use of medical equipment in hospitals, clinics, medical and rehabilitation facilities.
Our services include tests and certifications related to CE marking, and we also hold national and international accreditations for the certification of QM systems in accordance with ISO 13485.
In addition, we are approved for the certification of active and non-active medical devices and products, as well as implantable medical devices, equipment in clinics for health protection,
TÜV NORD GROUP is accredited by ZLG, the Competent Authority. (NB 0044)
Download Area
↘ Factsheet ISO 13485.pdf
↘ Factsheet ISO 15378.pdf
※ ISO 15378 Primary Packaging for the Pharmaceutical Industry
ISO 15378 is the standard offered for the Quality of Primary Packaging for the Pharmaceutical Industry.
This standard specifies the Quality Management System requirements for leading packaging manufacturers in the pharmaceutical and medical device industry and assesses their ability to consistently provide safe and reliable packaging.
Primary packaging is placed in direct contact with medical products and packaging materials include aluminum, containers/components, plastic films, metal sheets, glass, laminates, plastics and rubber.
Suppliers of primary medical packaging must demonstrate the quality of their manufacturing process through the implementation of a quality management system (QMS) and good manufacturing practices (GMP).
ISO 15378 integrates requirements with ISO 9001 as well as specific principles of Good Manufacturing Practice (GMP).
This enables manufacturers to manage product efficiency and quality, reducing the potential for product contamination and mitigating safety risks.
An implemented ISO 15378 certified Quality Management System (QMS) demonstrates the ability to consistently meet customer requirements, legal requirements and applicable international standards.
Prove the quality of your primary packaging QMS with ISO 15378 certification.