ISO 13485 helps companies to make positive, permanent quality and process improvements. The main aim of ISO 13485 is to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose. ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation and servicing such as added requirements on record-control, sterilization and risk management.

Regards from ISO 13485 Consultancy & certification services .

Certification to the standard requires an organization's quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit.

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Obtaining an ISO certification for a medical device is a meticulous process that involves rigorous compliance with international standards to ensure the safety and efficacy of the device. It typically begins with the manufacturer conducting a thorough risk analysis and quality management system (QMS) evaluation.

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