Quality Management

Leveraging our ISO- and FDA-compliant Quality Management System (QMS), our team works closely with each healthcare client to ensure that a well-managed and well-documented solution is prepared for regulatory review, with exacting technical and usability process rigor.

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About Our QMS

We collaborate with clients to craft a development plan that either integrates Essential’s QMS or aligns with their own. We produce design-related records for inclusion into the project’s Design History File and Device Master Record. Essential’s Quality Management System complies with EN ISO 13485:2003 and FDA 21 CFR Part 820. We create a development environment that insists on safety, efficacy, and usability, using the following frameworks:

Risk Management

Our quality system incorporates risk management activities throughout the design and development process in compliance with ISO 14971:2007. Our approach includes tasks to identify potential hazards, evaluate risks, and incorporate risk mitigation and control measures, as necessary. All Design Reviews include a careful review of Risk Management activities focused on the safety and efficacy of the device design.

Usability Engineering

Our user-centered design and development approach incorporates usability engineering methodologies to conform with IEC 62366:2007. The objective is to develop a product that is safer and more effective, with a reduced likelihood of use error occurrence and an increased likelihood of use error detection and correction.

Design Control

Design control is managed within an ISO 13485:2003 and FDA 21 CFR part 820 compliant process. Essential will generate many deliverables during a project for inclusion in the Design History File. Elements may include:

  • Development Plans
  • Requirements and Specifications (Design Inputs)
  • Hazard Identification/Risk Analysis
  • Usability Engineering File
  • Design Review records, presentations, and minutes
  • Engineering CAD databases and drawings
  • Verification testing protocols and reports, including Trace Matrix
  • Change order records