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ISO 13485: 2016 MDSAP Gap Analysis

ISO 13485: 2016 is the most recent version of quality management system (QMS), specifically for medical device manufacturers and is now considered the ‘gold’ standard.

Manufacturers have until March 2019 in order to update their current ISO13485 QMS to this latest version.

In addition, if it’s your intention to access US, Brazilian, Japanese, Australian and/or Canadian markets you will be required to comply with the requirements of the Medical Device Single Audit Program (MDSAP).

The MDSAP program involves a recognised certification body conducting a single regulatory and quality audit of a medical device manufacturer which aims to satisfy that all the relevant requirements for the participating regulatory authorities have been implemented.

At Advena we have experts who specialise in guiding manufacturers to compliance whether it’s ISO 13485: 2016 or with the additional requirements of MDSAP and the first logical step is to perform a gap analysis.

The Advena gap analysis will evaluate your QMS and assess your level of compliance, identifying any gaps, deficiencies or nonconformities when comparing to your current QMS to the standard you wish to achieve.

After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Advena can upgrade your QMS for an agreed fee.

This service is particularly helpful for SME’s and start-up organisations whose depth of resources may not allow for a gap analysis to be conducted internally.

For more information on how Advena can assist with assessing your QMS to either ISO13485:2016 or to include the requirements of MDSAP certification or even to implement a new QMS please contact the Advena team.

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