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Description
Medical device manufacturers and clinical investigators are responsible for conducting investigations to demonstrate safety and effectiveness of Class III devices and those on the Class II/III cusp. To be successful, sponsors and investigators need to skillfully approach the FDA as a collaborative partner. There are several opportunities to work with the FDA, from pre-submission correspondence through marketing application.
This webinar examines the regulatory touchpoints with the FDA during medical device development, with an eye toward uncovering those practical strategies that a device sponsor or investigator can take to streamline the path to market clearance or approval.
Audience
Compliance Professionals, Faculty and Post-Docs, General Counsel, Principal Investigators, Research Administrators, Sponsors
Meet the Presenter
Robert Michalik, JD, RAC – RegulatoryPro Consulting
Robert Michalik is an FDA regulatory attorney and founder of RegulatoryPro Consulting, a firm providing general and specialized services to biopharmaceutical and medical device clients. Mr. Michalik has over 30 years of experience working in the biopharmaceutical and medical device industries and earned degrees in biochemistry (BS) and law (JD). He counsels clients in range of technical, quality and regulatory areas relating to new product development and commercialization activities.
