NovaQual simplifies compliance for FDA & ISO regulated industries.
Our consulting services offer a systematic approach to quickly assist companies to grow and become stronger leaders in their respective industry; we provide solutions that maximize productivity and simplify industry and regulatory requirements. As a proven turnkey certification provider for ISO 13485 & ISO 9000, we can guarantee success with each compliance audit.
Our commercial and custom software solutions create efficient processes that businesses can implement and benefit from immediately.
What We Deliver
· 100% customer satisfaction
· 100% guarantee for 1st time ISO certification
· 100% guarantee of ISO & FDA Compliance using our gap assessment methodology
· 60- 90 days proven ISO certification process
· Perfect record on audits (zero findings)
· Deliver projects on-time and in-budget
· Over 15 years of experience
· Standard training on FDA, ISO 13485, ISO 14971, ISO 9000, CAPA, & Internal Auditor
· Navigation through FDA & ISO requirements per respective industry
· Clear, standardized path to full compliance
· 3rd party external auditor services (supplier, internal, or FDA mock audits)
Software Development, Quality Management Systems, ISO Consultation (ISO 9001, 13485, 14971, Title 21 CFR), Medical Device Consultation, PLC Monitoring Software (OPC Link), Training Management
2011 – less