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 CDG ensures that an organisation meets all guideline of ISO 13485:2016 & this is the reason why CDG 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
* 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
* Apply for ISO 13485:2016 certificate by submitting filled in ISO 13485 application form (Soft copy or hard copy). * Application form will be reviewed by our ISO 13485 auditor / expert & if accepted a quotation for ISO 13485 certification will be issued. * Upon submission of ISO 13485 certification fee, we will send you ISO 13485 audit plan (stage-1) & subsequently audit will be conducted. * After successful stage-1 audit closure of NC’s (if any), CDG will send you stage -2 ISO 13485 audit plan. After successful audit, auditor will recommend your organization for ISO 13485 certification. * Based on auditor’s recommendation & audit findings CDG’s certification authority will take decision for grant of ISO 13485 certificate
Now ISO 13485:2016 certification standard has come with many changes. Few important changes are as follows-
Flexible – New standard ISO 13485:2016 is more flexible as it allows you to make exclusions in section 6, 7 & 8 if it can be justified while in old standard ISO 13485:2013 exclusion was permissible only in section 7. In this way new standard ISO 13485:2016 is more flexible.
Regulations – In old standard ISO 13485:2013 a QMS had to established based on requirements of the standard & product, while in new version ISO 13485:2006 emphasis has been given on meeting regulatory requirements. Now QMS has to be established encompassing applicable regulatory requirements.
Risk Based Approach – In old version risk analysis approach was applicable to ‘product realization’ only, while in new version ISO 13485:2016 risk based approach is applicable to all processes of QMS
Enhanced Record Keeping – New standard ISO 13485:2016 expects you to keeps record of supplier monitoring, evaluation & re-evaluation. Now privacy has to be maintained in maintaining confidential health information.
Product Realization – New standard ISO 13485:2016 says to establish procedures for storage, handling of products, traceability, measurement & revalidation in addition to requirements of old standard ISO 13485 which required procedure for verification, validation, monitoring, inspection & testing
Training of Users – The new standard ISO 13485:2016 says to educate / train the user about product safety & regulatory norms.