Richard Janosko, RAC, Medical Device Regulatory Affairs Consulting
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About me:
I am an experienced Medical Device Regulatory Affairs Consultant. I understand the engineering, manufacturing, marketing and regulatory needs of both large and small medical device manufacturing organizations. My background is rooted in medical device engineering and development. I have over thirtyfive years experience in medical device companies from hands-on engineering, to top level Development Engineering and Regulatory Affairs management for United States, European and Asian companies.
My FDA and ISO medical device regulatory affairs background includes positions as the domestic and International Regulatory Affairs Director for Siemens Ultrasound Division and Siemens Oncology Care Group, as well as Regulatory Affairs Consultant to medical device companies in the United States, Canada, Asia, and Europe.
My fourteen years of consulting work has included diverse experience with medical device manufacturing companies from start-ups to international giants. Working closely with FDA staff at national, regional, and district offices, I represent my clients in matters ranging from new product "approvals" to good manufacturing practices compliance audits, FDA Form 483 responses, Warning Letters and consent decrees.
My work has included many successful "high-tech" product 510(k) submissions including FDA marketing approvals for 3-D diagnostic imaging workstations, Anesthesiology and Respiratory devices, Surgical devices, Radiation Therapy devices, Diagnostic Ultrasound devices and In Vitro Diagnostics devices.
I am certified by the Regulatory Affairs Professionals Society, Washington, D.C., and affiliated with the American Society for Quality and the Association for the Advancement of Medical Instrumentation.
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