ISO 13485:2016 Certification

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 of ISO 13485:2016 Certification

• 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