Enabling Business Success through Quality System Control and Regulatory Compliance for the Medical Device Industry
Since launching a consulting career in 2015, Ron has worked with various international medical device companies, helping them improve the efficacy of their quality management systems and regulatory compliance. Here is a summary of the various projects and audits in which Ron has been involved or lead:
- Independent contract consultant for DEKRA Business Assurance (www.DEKRA.com), performing quality management system certification audits to ISO 9001:2015 and ISO 13485:2016.
- Provided quality management system process improvement guidance and training to an international medical device company, including audit to U.S. Title 21 CFR Part 820 and FDA QSIT audit technique
- Provided process and system assessment, process map and recommendations to promote a more effective service and repair operation for an international medical device company
- Lead auditor, 3rd party FDA 21 CFR Part 820, ISO 13485, ISO 14971 and FDA QSIT audit, including a review of product, process, system and software validation activity.
- As a member of a 16 person FDA Quality Systems Regulation (QSR) remediation team, led corrective action effort to bring into QSR compliance supplier and purchasing controls of an international medical device company headquartered in Japan.
- Consultant team leader, responsible for simplification and harmonization of a world-wide medical device product development and design control process of an international medical device company across 13 global product design centers.