ISO 13485:2016 Requirements and Compliance to Latest Updates
February 28, 2019 - Online Event ON CAWebinar Compliance
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Key changes to the ISO 13485:2016 Effective Gap Assessment with ISO 13485 Updating your procedures to ensure compliance on an ongoing basis Observing every individual element that had been enhanced under ISO 13485: 2016 Successfully auditing to the new standard (closing all CAPAs from the audit) Changes in the control of nonconforming products and CAPA expectations Training employees with the new procedures to ensure compliance to the new ISO standard? Smart tips to ensure implementation and maintenance of the changes in your QMS EU Notified-Body expectations under ISO 13485: 2016 and the MDR – with the recent major revisions to both How can a company develop and maintain a dual QMS (EU and USFDA) and prepare for additional Geographies associated with MDSAP? Alignment of MDSAP for ISO13485:2016 for readiness to expand your market Discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit Maintaining overall compliance under increasing regulatory expectations Similarities and differences in the FDA and ISO13485:2016, after FDA has taken the path of MDSAP how do you continue to comply to ISO13485:2016?