Services · QA & regulatory

QA, compliance and regulatory.

Verification, validation and the regulatory evidence trail that lets medical software clear audit, the first time.

Overview

Quality built in from the first commit, not inspected in at the end.

We run verification and validation against IEC 62304, manage risk under ISO 14971, and align the work to your ISO 13485 quality system.

We prepare the documentation regulators expect, including design history files, traceability matrices and the evidence behind test results.

We also support assembling the documentation required for FDA procedures and EU MDR conformity assessment.

Information security practices align to ISO 27001, and networked systems are prepared for the requirements of the NIS2 directive.

In practice

Every requirement traced to the test that proves it.

Traceability that holds up when the auditor arrives.

Requirements on one side, and the verification results that prove they are met on the other. Between them we build a fully traceable, unbroken link.

We build the traceability matrix continuously, in parallel with development.

This way design history, risk controls and test evidence form one coherent system, rather than something reconstructed at the last minute before a deadline.

The same consistency extends to information security.

For connected systems we establish ISO 27001 information-security practices and support NIS2 readiness.

Where the device risk profile calls for it, we perform threat modelling and produce a software bill of materials (SBOM).

What this covers

The evidence trail, done properly.

Verification & validation

V&V planning and execution against IEC 62304 software lifecycle requirements.

Risk management

ISO 14971 hazard analysis, risk control and residual-risk evaluation.

Design history & traceability

Design history files and requirement-to-test traceability matrices.

Regulatory submissions

Documentation aligned with FDA 510(k), De Novo and EU MDR pathways.

Test automation & coverage

Growing automated coverage and regression suites that keep regulatory pace.

Information security

ISO 27001 information security and NIS2 readiness for connected systems.

Talk to us

Need to clear audit with confidence?

Tell us where your product is in its lifecycle. We will tell you what it takes to get the evidence right.

Email the team