Services · Teams who need independent V&V evidence for a submission
Verification & Validation
RND verifies medical device software with a team that is independent of the developers, and supports software validation when a project calls for it. Separating V&V from software development gives an honest assessment of the work, while doing both inside one ISO 13485-compliant quality management system keeps the work efficient and the teams in close communication. The result is independent evidence, traced to IEC 62304 and 21 CFR Part 820.30, that your software meets its requirements.
Request a V&V engagement
Independent by structure, not by scheduling
Most software teams verify their own work. We do not. RND keeps development and verification & validation as separate teams under a single ISO 13485 quality system, a rare structural asset. The result is verification evidence a reviewer can trust, because the people producing it did not also write the code.
What we deliver
- Test plans and protocols derived from your requirements and risk file.
- Verification reports with results a reviewer can follow, plus validation protocols and reports when your project needs them.
- A traceability matrix, requirement → design → test → result.
- Class-appropriate lifecycle evidence, verification matched to the software’s IEC 62304 safety class (A, B, or C).
- Regression testing as the software changes through its lifecycle.
On your software or ours
We verify software we built and software we did not. Teams bring us an existing product, sometimes one where confidence in the original vendor has slipped, and we produce the independent V&V evidence needed to move a 510(k), De Novo, or PMA forward. Our software has never been the reason a submission we supported stalled, and independent verification is a large part of why.
- 2 teams · 1 QMS
- Separate development and V&V teams under one quality system
- 25+
- 25+ years in business
- 15+ yrs
- Engineers average 15+ years of experience
One partner, end to end
Software built alongside the instrument.
RND writes and verifies the software. Gener8 designs and manufactures the instrument, cartridges, and consumables around it, mechanical, electronics, optics, and microfluidics, under one roof. Software, device, and disposables from a single partner.
Explore Gener8 capabilitiesFrequently asked questions
- Why do separate development and V&V teams matter?
- Because a reviewer trusts evidence produced by someone other than the author. When the team that verifies the software is independent of the team that wrote it, the verification is a genuine test rather than a confirmation of the developer's own assumptions. That independence is built into how our teams are organized.
- What is the difference between verification and validation?
- Verification confirms the software was built right, that it meets its specified requirements and design. Validation confirms it is the right software, that it meets user needs and intended use. 21 CFR Part 820.30 requires both, and they produce different evidence.
- Can you do V&V on software you did not build?
- Yes, and it is a large part of what we do. We take the existing requirements, design, and code, work to the software's designated IEC 62304 safety class (A, B, or C), and produce the verification evidence your submission needs, with validation support where the project calls for it.
- Do you produce the traceability matrix?
- Yes. We deliver traceability running requirement to design to test to result, so a reviewer can follow any requirement through to the evidence that it was verified. That matrix is central to the submission, it lets a reviewer trace any requirement to the evidence it was met.
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