Medical Device & Equipment Manufacturing Law

Bringing a medical device to market involves more than just great design. Companies also face regulatory requirements, funding challenges, IP considerations, and risk management. Dickinson Wright’s Health Law Group advises medical device and equipment manufacturers at every stage, from startups to global companies, helping them navigate FDA and international regulations, commercial transactions, financing, IP protection, and product liability issues.

Our Services

Regulatory & FDA Counseling

We help clients navigate FDA requirements from premarket strategy to post-market compliance. Our work includes:

• Product classification, investigational device submissions, 510(k), and premarket approvals
• Post-market reporting, recalls, labeling, advertising, reimbursement, and supply chain issues
• Import/export considerations and government contracting
• Responses to FDA inspections, Form 483 observations, and warning letters

Transactions & Corporate Finance

Our team advises on acquisitions, divestitures, mergers, restructurings, and private transactions in the health technology sector. We also support financing strategies, connecting clients with venture capital, private equity, institutional lenders, and banks to secure funding for growth.

Intellectual Property

We protect and manage innovations through patent drafting, prosecution, licensing, and enforcement. We also provide opinions on patentability and infringement, conduct IP audits and due diligence, and manage global filing strategies across the U.S., Asia, and Europe.

Litigation & Risk Management

We work proactively with clients to identify risks and minimize disputes. When litigation is unavoidable, we represent companies with a focus on efficient, cost-effective solutions that protect both business operations and reputation.

IoT Regulatory Compliance

We work with clients to ensure that “connected” medical devices that collect and report health data can demonstrate compliance with federal and state data protection, cybersecurity, spectrum access and equipment authorization regulations.