Now privacy has to be maintained in maintaining confidential health information.
#Iso 13485 certificate iso#
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 QMSĮnhanced Record Keeping – New standard ISO 13485:2016 expects you to keeps record of supplier monitoring, evaluation & re-evaluation. Now QMS has to be established encompassing applicable regulatory requirements. 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. In this way new standard ISO 13485:2016 is more flexible. Few important changes are as follows-įlexible – 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. Now ISO 13485:2016 certification standard has come with many changes. * Based on auditor’s recommendation & audit findings CDG’s certification authority will take decision for grant of ISO 13485 certificate Changes Between ISO 13485:2003 & ISO 13485:2016 After successful audit, auditor will recommend your organization for ISO 13485 certification. * After successful stage-1 audit closure of NC’s (if any), CDG will send you stage -5 audit plan. * Upon submission of ISO 13485 certification fee, we will send you ISO 13485 audit plan (stage-1) & subsequently audit will be conducted. * Application form will be reviewed by our ISO 13485 auditor / expert & if accepted a quotation for ISO 13485 certification will be issued. * Apply for ISO 13485:2016 certificate by submitting filled in ISO 13485 application form (Soft copy or hard copy). * 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 ISO 13485 Certification Process * ISO 13485 works as a brand ambassador of your medical device hence your sales & marketing cost will reduce. * ISO 13485 certificate is universally recognized & it covers regulatory & statutory norms of most of countries, your product gets an expended market access. * ISO 13485 improves performance or products & processes of a medical device company. 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 Certification We are a pioneer ISO 13485 certification body of India. Our ISO 13485 certification process is result oriented & customer focused. 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. ISO 13485 certificate satisfies potential customers & stakeholders with the fact that a device has been manufactured following internationally recognised ISO 13485 standard.
ISO 13485 is basically a QMS for medical device industry that is why it is also known as ‘MD QMS’. 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 13485:2016 is a specific certification standard for medical device industry.