About

Michael Gross is the Principal Consultant of Chimera Consulting®, specialising in quality assurance, regulatory affairs and technical development of drugs, biologics, medical devices and combination products. He also heads the Combination Product Training Institute®, which provides professional training programs on combination product topics. Michael holds a PhD in Organic Chemistry and conducted post-doctoral research in biochemistry at the National Institutes of Health. He is a former FDA reviewer and inspector. Michael worked for 30 years in senior quality, compliance and regulatory affairs roles for a number of large and small pharmaceutical and medical device companies. Today, he provides an influential industrial perspective on the regulation of combination products and is a frequent speaker on combination products topics and has published numerous articles in regulatory and scientific publications.

Contributions

RESPIRATORY

FDA ISSUES FINAL GUIDANCE ON MEDICAL DEVICE HUMAN FACTORS STUDIES

Michael Gross and Adam Shames discuss US FDA draft recommendations on human factors validation which are part of the design validation requirement of device design controls.

More contributions

INJECTION

US FDA ISSUES GUIDANCE ON HUMAN FACTORS STUDIES FOR COMBINATION PRODUCTS

Adam Shames and Michael Gross summarise the US FDA’s recently released draft Guidance: “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development”.

PREFILLED SYRINGES

QUALITY & SYSTEMS USABILITY REQUIREMENTS

Michael Gross and Adam Shames discuss US FDA quality system requirements for combination products, especially Design Controls, which includes the requirement to validate the design of the medical device constituent part of a combination/borderline product.