Alacrita

Jim has a depth of experience in development, manufacturing, quality systems and regulatory affairs in the medical devices and in vitro diagnostics industries.

After a 15 year career in US and European diagnostics and device corporations, his consulting experience has spanned a broad range of products, technologies and clients.

He has held interim management posts in companies developing molecular diagnostics, clinical trial software, electro-surgery, lung ventilation and oxygen generation & CO2 absorption products.

In addition, he acts as a senior representative for several Notified Bodies implementing consulting, training and auditing assignments worldwide; he has completed over 300 device and diagnostics audits world wide.

His recent work has focused on the Medical Devices Directives and the IVD Directive, with particular emphasis on compliance with product safety requirements and quality system requirements.