The international, process-oriented standard ISO 13485 forms the basis for certifying quality management systems at companies that manufacture or sell medical products, or that are involved in production as part of the supply chain.
ISO 13485 builds on ISO 9001 but contains additional industry-specific requirements for medical technology. The standard is extensively harmonized with the applicable EU guideline 93/42/EEC for medical products.
ISO 13485 certification helps you document compliance with the relevant regulations for manufacturing medical products and meet all major industry requirements, even as a supplier to the medical products industry. In eases access to new markets and helps attract new customers.
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