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.