TIC - Techeuropa Inspection and Certifications Pvt. Ltd. also provides ISO 13485 Certification.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
The processes required by ISO 13485, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.