John has established himself as a leader in the overall integration and execution of regulatory affairs & quality management systems in the medical device design, development and manufacturing continuum.    During his 30 years of experience in the medical device field, he has successfully implemented regulatory approvals for various class devices in both the USA and EU, he has successfully mitigated recall and market withdrawal situations for large and small companies.  He has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU, Canadian and other global regulations.  In addition, he has successfully remediated systems and records for companies under rigorous regulatory oversight.  John is adept at providing practical solutions in compliance with the FDA Quality System Regulation (QSR), ISO13485:2016, ISO 9001:2015, ISO14971, ISO10993, 60601-1, 62304, ISO 14155, 62366-1, HE-75 and a broad range of other technology, device specific standards and regulatory standards including design controls, process validation and statistical analyses.  John is widely recognized for presentations and leadership in his field.