Edward C. Wilson, Jr.
Whether you're a multinational corporation or a growing business looking to expand in the U.S. market, complying with the FDA's web of medical device regulations can be challenging and resource intensive.
There's heightened scrutiny on everyone, and the consequences of not following the rules are substantial. Get it wrong, and you could face warning letters, civil monetary penalties, injunctions, product seizures, criminal liability, difficulty closing deals, and damage to your reputation. Ted Wilson has over 25 years of experience in assessing business and legal risks of regulatory compliance issues and finding ways to mitigate such risks.
Ted has helped companies of all sizes find workable business solutions to complex post-market compliance issues. Whether it is responding to FDA inspectional observations or a warning letter, assisting in the defense of a criminal investigation, conducting an internal investigation of alleged regulatory violations, executing product recall strategies, or interpreting the FDA's complex adverse event report and advertising and promotion requirements, Ted helps navigate the complicated regulatory environment in which medical device companies that market products in the U.S. must operate.
Areas of Focus
Represented a major medical device company in an internal investigation of claims brought by employees regarding alleged FDA violations.
Assisted in the response to a warning letter issued to a global company regarding alleged quality system and medical device reporting violations.
Assist in executing a global corporation of medical device products and in complying with international reporting obligations.
Assist in the creation and execution of advertising and promotion guidelines to comply with government settlement agreements.
Assist in the preparation for, and defense of, international inspection in follow up to import ban.
Assisted in the settlement of civil monetary penalties imposed on global medical device company.
Assisted in the settlement of consent decree of permanent injunction and ensuing compliance plan.
Defended a major medical device corporation in a criminal investigation regarding the shipment of alleged adulterated and misbranded devices.
Healthcare: Life Sciences
Legal 500 U.S.