Enabling Business Success through Quality System Control and Regulatory Compliance for the Medical Device Industry

Ron Makar, Owner & Principal Consultant

+1 302.494.5978



Ron has over thirty-five years of experience in the design, manufacture and support of medical devices.

Dedicated, well-organized, quality professional with vast experience in product, process and quality engineering, auditing, product development and commercialization, systems development and support, regulatory compliance, production supervision, and quality management.  Multi-faceted with thirty-five years of experience in world-class medical device and biotech manufacturing operations, Ron’s professional background includes work experience in the areas of in vitro diagnostic medical devices, digital imaging equipment, interventional devices, bio-based materials, and bio-polymer devices and delivery systems.

Ron has established and maintained several management systems to comply with ISO and FDA regulated quality system standards, regulations and business requirements, including support for technical file documentation.  Ron specializes in establishing product development and commercialization products regulated by:

•    U.S. Title 21 CFR Part 820 (FDA Quality Systems Regulation)

•    ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes)

•    ISO 14971:2012 (Medical devices – Application of risk management to medical devices)

Ron is a Senior member of the American Society for Quality (ASQ), of which he has been an active member for twenty-six years.

See Ron’s listing of professional accomplishments in the “About Ron” section.

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