Quality Consulting for the Pharmaceutical, Medical Device and Biopharmaceutical Industries.

Founded in 2005, Quality Edge provides, R&D Quality Assurance, Medical Device Engineering Quality Assurance, Manufacturing Quality Assurance and Compliance and technical consulting services to clients around the world. • GMP and QSR (21 CFR Parts 820, 210, 211,58,56 and 11) • ISO 13485:2016 • ISO 9001:2015 • ISO 17025 • ISO 14644 (1 to 8) • Medical Devices Directive (European Council Directive 93/42/EEC) • EU Guidelines to Good Manufacturing Practices, Medicinal Products for Human and Veterinar...

Founded in 2005, Quality Edge provides, R&D Quality Assurance, Medical Device Engineering Quality Assurance, Manufacturing Quality Assurance and Compliance and technical consulting services to clients around the world. • GMP and QSR (21 CFR Parts 820, 210, 211,58,56 and 11) • ISO 13485:2016 • ISO 9001:2015 • ISO 17025 • ISO 14644 (1 to 8) • Medical Devices Directive (European Council Directive 93/42/EEC) • EU Guidelines to Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use • Canadian Medical Device Regulations • Japan's Pharmaceutical Affairs Law (JPAL)