Manufacturer, Distributor, Service Provider

Noblitt & Rueland

Irvine, California, United States

About Company:

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.