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Contact SupplierWe are the leading Service Provider in the industry who provides ISO 13485 Certification services. These services are imparted under strict supervision of proficient professionals making use of best tools and techniques on offer to ensure we deliver the utmost quality. Our services are widely acknowledged by our clients for prompt response and impeccable execution. We make sure the services on offer are performed in the stipulated time frame. Apart from all these features, we also make sure to go easy on our clients’ pockets by offering these services for a nominal fee.
What is ISO 13485?
Benefits of ISO 13485
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. To ensure this, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.Organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 because certain points have been excluded in ISP 13485.
Benefits of ISO 13485