ISO 13485:2016 is a specific certification standard for medical device industry. ISO 13485 certification fulfils your needs related to production control, quality management, regulatory compliances & specific needs related to production of a particular medical device. ISO 13485 is basically a QMS for medical device industry that is why it is also known as 'MD QMS'.
ISO 13485 certificate satisfies potential customers & stakeholders with the fact that a device has been manufactured following internationally recognised ISO 13485 standard. ISO 13485 audit by QCPL ensures that an organisation meets all guideline of ISO 13485:2016 & this is the reason why QCPL is an industry trusted ISO 13485 certification company. Our ISO 13485 certification process is result oriented & customer focused. We are a pioneer ISO 13485 certification body of India. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization
Benefits
- ISO 13485 improves performance or products & processes of a medical device company.
- ISO 13485 certificate is universally recognized & it covers regulatory & statutory norms of most of countries, your product gets an expended market access.
- ISO 13485 works as a brand ambassador of your medical device hence your sales & marketing cost will reduce.
- ISO 13485 certification gives faith to your customers that device is safe for use & it meets requirements of most of recognized technical standards related to medical device
Changes Between ISO 13485:2003 & ISO 13485:2016
Now ISO 13485:2016 certification standard has come with many changes. Few important changes are as follows-
