Our Services

Quality

  • Quality Management System (QMS) creation, implementation, support
  • Internal Audit
  • Non-conformances/CAPAs

Regulatory

  • Audit/Inspection Support
  • Remediation Activities

Risk Management

  • Risk Assessments
  • Risk Management Files
  • Post Market Surveillance

Supplier management

  • Supplier Audits
  • Supplier Risk Assessments
  • Supplier Management

Verification & Validation

  • Master Validation Plan Guidance
  • Protocol Development
  • Execution Oversight

 

R&D

  • Design Controls
  • New Product Launch Support
  • Sustaining Engineering Support

Training

  • ISO 13485/FDA 820
  • Design Controls
  • Transfer to Manufacturing

Manufacturing Support

  • DMR Creation/Review
  • Transfer to Manufacturing

Continuous Improvement

If you can’t find the service you are looking for, please reach out.  Just like you, we are continuously improving!  We will work with you to identify what support you need and tailor a solution that works for you.  We will adjust as needed to accommodate your business needs as they change and work with you to give you the support you need because we get it!