The Problem:

US Food and Drug Administration (FDA) regulation 21 CFR 820 lays out comprehensive quality guidelines for all medical device manufacturers, which must be explicitly followed in order to pass FDA certification audits and deliver a safe and effective medical device. Over time, significant resources must be allocated to maintain the process of building a medical device, which add overhead and increase development costs, 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 FDA 21 CFR 820 testing requirements focused on computerized hardware and software. By leveraging nResult’s exclusive On-Demand philosophy, many aspects of 21 CFR 820 testing can be streamlined and improved leading to:

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

Rather than maintain an internal full time team to handle 21 CFR 820 Medical Device testing 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 testing needs.
Beyond FDA mandated testing nResult introduces other quality practices including ad-hoc and exploratory testing to the development process. These techniques can uncover issues earlier in the development cycle and can reduce the need for repeated FDA testing.

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.

Design Validation Testing / Medical 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:

• Accessibility Testing >
• Compatibility Testing >
• Functionality Testing >
• Web Application Testing >
• Certification >

Quality Audit

nResult will provide comprehensive testing and auditing to verify Quality Process and procedures are correct. 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 the medical device development process.