About The Author
Trevor Lewis is an independent medical device consultant who has worked on thousands of medical device projects over a career of more than 30 years. He has trained medical device regulators from all over Europe, China and India, on EU medical device regulations, and has provided advice to regulators globally.
The significant volumes of documentation that medical technology manufacturers must generate in support of their products, as they make their way through trials, regulation, reimbursement and then through post-market surveillance and clinical follow-up, has a dual aim: to show that manufacturers have been duly diligent, professional, and ethical in their work; and to demonstrate that what they have done is in the best interests of patients – those who are at the center of their concerns.
