Working within regulated industries for 30+ years, our experience has allowed us to gain insight into developing, implementing and managing Quality Management Systems to meet a wide range of regulated industries.  We have worked directly with regulatory authorities in the US, Europe and South America to assure compliance.

In many cases, organizations need to make sure they are compliant to several different standards.  We have successfully integrated multiple standards into one seamless, efficient, practical and compliant system.

Systems implemented:
ISO 9001
ISO 13485
Medical Device Single Audit Program (MDSAP)
US CFR Title 21 Section 211
US CFR Title 21 Section 820
ISO 17025
ISO 14001

Standards expertise:
ISO 9001
ISO 13485
ISO 14971
IEC 62366
ISO 17025
European Union Medical Device Regulations