Medical Device Testing

The Problem

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US Food and Drug Administration (FDA) regulation 21 CFR 820 lays out comprehensive quality guidelines for all medical device manufacturers.  A high level perspective, these guidelines must be explicitly followed in order to both pass FDA certification audits and deliver a safe and effective medical device.  The required processes, procedures, and infrastructure to meet 21 CFR 820 can be immense and at times can eclipse the actual development requirements of a product.  Over time significant resources must be allocated to maintain the process of building a medical device rather then the actual act of building said device.  These resources add overhead and increase development costs, development time, and other unforeseen scheduling issues.

The Solution

Through extensive research, client collaboration, and exhaustive trials, nResult is proud to offer Medical Device Testing – a service specifically designed to address the challenging and expensive 21 CFR 820 testing requirements.  By leveraging nResult’s exclusive On-Demand philosophy, all aspects of 21 CFR 820 testing – from design to delivery – can be streamlined and improved leading to:

  • Improved product quality
  • Reduced time to market
  • Reduced overhead costs

Rather then maintain an internal full time team to handle 21 CFR 820 needs, let nResult’s on-demand medical device experts complement your internal resources as needed.

By working within existing client Quality Policy requirements, nResult can quickly scale up to meet a variety of medical device needs:

Medical Device Testing Services

Quality Performance Review

nResult will review the current Quality Policy to verify it is adequate, if it is being properly followed, and provide insight into improvements in both efficiency and overall product quality.  Traditionally done in a consulting role, this can be carried out at predetermined review intervals.

By utilizing nResult for the Quality Policy review, relevant parties are freed up to address any issues discovered during the review rather then carry out the actual review themselves.  This leads to time and cost savings and a reduction in scheduling issues.

Design Review

Expert nResult engineers provide vital QA perspective during design reviews; a process that adheres to nResult’s belief in the “test early, test often” theory of QA.  nResult engineers can point out design flaws, question design choices, and begin test planning while a device is still in its design phase.

Design Validation Testing / Device Testing

Depending on specific project needs, nResult will provide both on-site and off-site test execution and reporting utilizing various methods.  Testing will utilize new or existing test tools and processes including:

Quality Audit

nResult will provide comprehensive testing and auditing to verify Quality Process and procedures are correct.  These tests will ensure the quality system is in compliance with quality system requirements and determine effectiveness of said quality system.

If any deficiencies are found, nResult experts will carry out re-audits.  Every step and result of every audit will be documented as required.  Comprehensive reports will be created of each audit and reported promptly to the required parties.  As designated by FDA 21 CFR 820, every audit will be carried out by a team of independent shareholders.

Engage nResult

Medical Device Testing encompasses a wide range of services, each of which brings its own benefits.  While no two projects or processes are the same, nResult’s unique blend of expertise, experience, and independent perspective can help improve product quality, reduce development costs, and improve time to market.  Engage nResult to learn how Medical Device Testing can improve every aspect of medical device development.