Regulatory concern and business objectives mus t concur for organizations to prevail in a globalization era. Our GlobalNet team, through answering inquiries - questions can provide you with insightful strategic planning, operating practices, quality, FDA QSR, and ISO 13485 | CMDCAS implementation information toward certification.

Highly responsible and trustful organizations such as GE Medical Systems, Kappler, ITL Australasia, Grifols and Kimberly-Clark Professional Health, Gyrus PLC are a few of the organizations from which we gain competence.

Training venues in the market, as necessary, include:

  • Training,
  • Assessment,
  • Assist in Regulatory Affairs,
  • CE Mark Assistance,
  • FDA QSR Planning,
  • ISO 9001 / ISO 14000 within the Medical Sector,
  • Provide information leading to design and development of Quality Systems for FDA cGMP QSR compliance,
  • Process Verification / Validation support, and
  • CMDCAS support
  • Advanced - Audit Team Leader ISO 13485 FDA cGMP 21 CFR Part 820