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, design history files, traceability matrices and test evidence, and support submissions across FDA and EU MDR pathways. Information security follows ISO 27001 with NIS2 readiness.

In practice

Every requirement traced to the test that proves it.

Traceability that holds up when the auditor arrives.

Requirements on one side, verification on the other, and an unbroken line between them. We build the traceability matrix as the work happens, so design history, risk controls and test evidence all reconcile rather than getting reconstructed under deadline pressure.

The same rigour extends to security: ISO 27001 information-security practices and NIS2 readiness for connected systems, with threat models and an SBOM where the device profile calls for it.

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.

More services

Medical Software Development Embedded Software Development Consulting & Project Management Implementation & Integration Training & Coaching

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