Our Expertise

Quality Management Systems
  • ISO and FDA compliant QMS implementation

  • ISO 13485:2016 upgrades

  • MDSAP implementations

  • Site QMS auditing services with certified Lead auditors

  • eQMS implementation, management and validation

  • CAPA system implementation, remediation and management

  • Document control systems implementation

  • calibration systems

  • ISO 14971 Risk management services

  • Training system development and implementation

  • CE Mark and other certification support services

Manufacturing Quality Assurance
  • Process Validation

  • Labeling and Inspection systems development and validation

  • Sterilization Quality services

  • Supplier Quality control

  • Supplier Management & Auditing

Regulatory Services
  • Risk Management- ISO 14971   

  • Design Verification & Validation 

  • Process Validation

  • Mfg Site Transfers

  • Change Control

  • CAPA / NCMR 

  • Complaints / Medical Device Reporting (US MDR) / Vigilance Reporting ( EU)

  • Supplier Controls / Changes

  • Standards Apllicability

Regulatory Affairs
Manufacturing and Distributions
ISO 9001 2016 and ISO 22716 Services
  • FDA Breakthrough Device Designation

  • FDA Humanitarian Use Designation (HUD) / Humanitarian Device Exemption (HDE)

  • FDA Investigational Device Exemption (IDE), Early Feasibility Study (EFS), Feasibility Study(FS)

  • Regulatory Strategy - US, EU, Health Canada, Australia 

  • Current EU Medical Device Directive (MDD) / Active Implantable Medical Device Directive (AIMDD) 

  • EU Medical Device Regulation (MDR)

  • Audits:

  • US FDA, EU FQA / Design Examination, MDSAP,  Australia TGA, Brazil ANVISA

 

  • Concept to distribution services provided

  • Have an Idea for a product and wantto bring it to life?  Call us

  • QMS implementation

  • Internal and supplier auditing

  • Training

  • Certification support services

 

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