Regulatory concern and business objectives mus t concur for organizations to prevail in a globalization era, yet national sovereignty prevailing. Our network of professionals team, through answering inquiries - questions can provide you with insightful strategic planning, operating practices, quality, FDA QSR, CYBERSECURITY, and ISO 13485 | CMDCAS (Canada) implementation information toward certification. Yet more important is the quality of life of consumers worldwide, as these sustain a global free market.

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:

  • Regulatory Framework (per sovereign nation),
  • Assessment,
  • Assist in Regulatory Affairs,
  • CE Mark Assistance,
  • FDA QSR Planning (with QSIT),
  • ISO 9001 / ISO 14000 within the Medical Sector,
  • QMS Healthcare,
  • 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 based publication ISO 13485 for regulatory purpose FDA QSR 21 CFR Part 820

In the USA its is the law that need be met and QMS MDD ISO 13485 may help toward the fulfillment of legal obligations and regulations, but ISO 13485 is no substitution to the law of sovereign nations within the free market.