Richard Janosko Consulting

Richard Janosko RAC, Medical Device Regulatory Affairs Consulting

Your ad hoc Regulatory Affairs Department

24 hour, on-call, when needed, regulatory assistance

FDA 510(k) Premarket Notification submission preparation

FDA and ISO 9000 Standard Operating Procedures development and customized employee training

FDA compliance support including FDA Form 483 and Warning Letter responses, recall assistance,  and ongoing regulatory support including regulatory research, regulatory strategy planning, and internal compliance audits

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Please note: Since 2003 I have reduced my consulting practice to limited assistance to several select old clients. I am not accepting new projects. Thank you.

Richard Janosko Consulting

2013 Richard Janosko Consulting. All rights reserved.