Whether it's a multinational corporation or a growing business looking to expand in the U.S. market, complying with the U.S. Food and Drug Administration's (FDA) web of medical device regulations can be challenging and resource intensive.

Ted Wilson has over 28 years of experience advising clients on complex regulatory, enforcement, and product submission matters throughout the total product life cycle of medical devices. He represents clients before FDA to help attain workable solutions to public health and safety emergencies, regulatory and business challenges, and compliance matters.

Ted has assisted hundreds of clients prepare for, defend, and respond to domestic and international inspections and audits. He has conducted numerous quality system audits and completed the ISO 9001:2008 3-Day Certified Internal Auditor with Medical Device Focus (ISO 13485:2016) training and the Medical Device Single Audit Program (MDSAP) 1-Day Overview Training through AQS Solutions (a DEKRA company).

In addition to extensive auditing, his work has included designing and implementing robust quality systems for medical device manufacturers, and responding to Form 483 inspectional observations, warning letters, and untitled letters.

Ted has defended companies in government investigations involving quality system and other medical device regulations, negotiated consent decrees of permanent injunction, and counseled clients under third-party certification audit obligations.

His experience in assisting medical device companies with public health and safety matters includes emergency preparedness operations, health hazard evaluation assessments, risk mitigation strategies, recall decision-making and execution, adverse event reporting, root cause investigations, and corrective action plans to address quality and safety issues.

Ted has assisted medical device companies in making product submission determinations for proposed device labeling, design, and manufacturing changes. He also has assisted in drafting numerous 510(k) notices, premarket approval (PMA) applications, and investigational device exemption (IDE) applications for a wide range of device technologies.