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Interactively incentivize team driven markets and accurate meta-services. Progressively engage cutting-edge catalysts for change after efficient potentialities. Professionally generate extensive process improvements for process-centric niche markets. Dramatically initiate end-to-end niches whereas integrated best practices. Professionally envisioneer ethical results rather than team building synergy.
Recent Works

Quality Engineering

Quality Engineering

We Are a Team of Engineers and Subject Matter Experts with a long experience in the Medical Device field, this allow us to quickly find the right approach for the projects, optimizing development basing on regulatory field, applicable international standards and previous experience with the biggest market leader companies.

We provide our experience and support in order to optimize or build up Your quality System in compliance with US and EU regulations.

  • Medical Device Manufacturing Process Validation
  •   Drug Manufacturing (Oral/liquid dosage) Process Validation
  •   Test Method Validation
  •   Cleaning Validation
  •   Supplier Quality Validation
  •   Electrical System Validation
  •   Utilities/HVAC Validation
  •   Computer System Validation (CSV)
  •   CAPA Owners/ Investigators
  •   Quality Assurance
  •   Thermal Validation
  •   Packaging Validation
  • Production Part Approval Process Review
  • PFMEA
  • Control Plan
  • Capability study review and validation
  • Corrective action recommendations\ 8D
  • Work extensively with management to resolve issues efficiently
  • Production line audits
  • Error proofing recommendations
  • Qualit21 CFR 800-1050 (devices)

•21 CFR 820 Quality System Regulation (GMP—Good Manufacturing Process)

•21 CFR 807 (510K)

•21 CFR 812 (IDE—Investigational Device Exemption)

•21 CFR 814 (PMA—Premarket Approval)

•21 CFR 11   (ERES—Electronic Records and Electronic Signatures)

•21 CFR 50   (Informed Consent)

•21 CFR 56   (IRB—Institutional Review Boards)

•21 CFR 58   (GLP—Good Laboratory Practices)Quality2