Manufacturer, Distributor, Service Provider
Noblitt & Rueland
Irvine, California, United States
Consulting services for medical and pharmaceutical industries. FDA and ISO quality systems, submissions, design control, risk management, hazard analysis, software development, electronic recordkeeping (Part 11), electrical safety (IEC 60601-1), reverse engineering and regulatory consulting services are available. Software compliance assessments, quality assurance, verification and validation, testing, product/software development; GMP, QSR, QSIT, and ISO auditing; and creation of 510(k), IDE, PMA, and CE mark submission services are offered. Training services are provided.