Contact: Frank O'Brien
Year Established: 2004
No. of Employees: 4
Key Clients: Boston Scientific, Covidien, Johnson & Johnson, Smith & Nephew, Thoratec, Varian Medical.O'Brien Compliance Management provides regulatory compliance management services to U.S., European, and other international medical device manufacturers. The firm helps clients to integrate safety features into their products' life cycles in compliance with applicable regulatory requirements. Areas of expertise include risk management, product safety, essential performance, and electromagnetic compatibility. International standards such as ISO 14971, IEC 60601, IEC 61010, and IEC 60950 are routinely applied.
