Noblitt & Rueland is the leading medical device consulting firm specializing in technical FDA & international regulatory issues including Quality Systems, Submissions, Design Control, Risk Management, Software, electronic recordkeeping (Part 11), electrical safety (IEC 60601-1) & regulatory consulting for FDA & Internationally regulated medical industries.

Noblitt & Rueland assists manufacturers in both the medical device and pharmaceutical industries. Our areas of expertise include FDA & International regulatory issues, quality systems, design control, risk management, software development, software quality assurance, software compliance assessments, independent verification & validation, software testing, reverse engineering, electrical safety and submissions. Noblitt & Rueland provides GMP-QSR-QSIT-ISO audits, software GMP audits, creation of 510(k), IDE, PMA, & CE Mark submissions including software sections, and numerous other technical regulatory services. Our clients have identified Noblitt & Rueland as a qualified supplier and have added us to their approved vendor lists. See our consulting section for additional consulting information. General and in-house training seminars are presented on FDA/International issues including GMP/QSR (Quality System Regulation), design control, risk or hazard analysis (including FMEA & FTA), software SQA (design and manufacturing), CE Mark/ISO 13485, electrical safety/EMC (IEC 60601-1). Our services integrate seamlessly with your current RA/QA and R&D efforts. We also assist other regulatory affairs consulting firms to provide additional support and expertise per their client requirements.

Consulting services Training Seminars  <<>> Rita Hoffman (Recall Branch Chief, U.S. FDA, CDRH) just added as an instructor in Complaint, MDR, Recall Course! <<>> June 21-25, 2010 July 19-23, 2010 Paradise Pier Hotel Disneyland Resort Anaheim, California In-house Training Seminars Consulting Opportunities

Disney's amazing World of Color and Summer Nightastic both set to open June 11.   Southern California   Training

 
Obtain your Free New GMP/QSR Pocket Reference. (Front Cover Image) Noblitt & Rueland has published a very handy, small pocket sized reproduction of the New GMP / QSR (21 CFR Parts 808, 812, and 820 Medical Devices; Current Good Manufacturing Practice (cGMP) Final Rule, Quality System Regulation, Oct. 7, 1996). It has been designed so that you may carry the regulation with you at any time. Carry it to a meeting, on the production floor, visiting a vendor, during an inspection, etc.You can get a copy for free ($8.95 Value) now. Certain restrictions apply.
 

5405 Alton Parkway  5A, #530
Irvine, California 92604-3718
USA

Telephone (714) 258-4646
Facsimile (714) 258-3990