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Services

Alquest services: Quality System & compliance services for medical device companies

Alquest develops and implements Quality System and Compliance strategies for manufacturers of medical devices including IVDs (in vitro diagnostics), biologics and combination products. We assist clients in a variety of ways including Quality System implementation, pre- and post-market compliance activities, risk management, and design control support.

 

How Alquest Can Help

  • Advisory and consultative support (hourly)
  • Implementation
  • Audits
  • Onsite staffing
  • Functioning as a virtual department
  • Emergency response
  • FDA interactions

We commonly help large manufacturers:

  • Improve or correct non-compliant Quality System processes, such as corrective and preventive actions, complaint handling, device tracking
  • Support product recall efforts
  • Correct non-compliances such as FDA 483 infractions and Warning Letters
  • Perform internal audits
  • Perform supplier audits
  • Assist with process improvements
  • Perform risk assessments

We commonly help startups and small manufacturers:

  • By functioning as a virtual (outsourced) Quality System department
  • Implement total Quality Management Systems compliant with the requirements of FDA 21CFR Part 820, and ISO 13485
  • Perform supplier audits

Various Other Tasks Alquest Performs

  • Gap analyses and pre-certification assessments
  • Comprehensive quality system development and implementation
  • Document control procedures and implementation
    • Paper-based and software driven Quality Systems
  • Work instruction development and process flow diagrams
  • Device Master Records (DMR) and Device History Records (DHR)
  • Customized training
  • Mock FDA/QSIT inspection
  • Part 11 compliance (electronic records and electronic signatures)
  • Quality records
  • Corrective and Preventive Action (CAPA) procedures and implementation
    • Root Cause Analysis
  • Complaint handling procedures and implementation
  • Medical Device Reporting (MDR) and vigilance reports
  • Assist with device recalls
  • Enforcement action resolution
  • Management review program development and facilitation