ISO 13485:2016 is a specific certification standard for the medical device industry. ISO 13485 certification fulfils your needs related to production control, quality management, regulatory compliances & specific needs related to the production of a particular medical device. ISO 13485 is a QMS for the medical device industry which 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 recognized ISO 13485 standards. ISO 13485 audit by CDG ensures that an organization meets all guidelines 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 in India. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization

Changes Between ISO 13485:2003 & ISO 13485:2016 

Now ISO 13485:2016 certification standard has come with many changes. A few important changes are as follows- 

Flexible – New standard ISO 13485:2016 is more flexible as it allows you to make exclusions in sections 6, 7 & 8 if it can be justified while in the old standard ISO 13485:2013 exclusion was permissible only in section 7. In this way, the new standard ISO 13485:2016 is more flexible. 

Regulations – In the old standard ISO 13485:2013 a QMS had to be established based on requirements of the standard & product, while in the 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 the old version risk analysis approach applied to ‘product realization’ only, while in the new version ISO 13485:2016 risk-based approach applies to all processes of QMS 

Enhanced Record Keeping – New standard ISO 13485:2016 expects you to keep a 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 the old standard ISO 13485 which required procedures 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.