Verification and validation that holds up in an audit
We test complex software from unit level to full hardware and software workflows, and document it so that every result traces back to a requirement. For medical device clients, that evidence is prepared for MDR and FDA review.
What QA covers
From requirements to an evidence package your regulatory team can submit.
Testing services
- Requirements engineering
- Test management and test engineering
- Unit, component, interface and integration testing
- System and end-to-end testing, including hardware and software workflows
- Firmware testing, test bench design and lifetime testing
Automation
- Classic test automation (Selenium, Playwright, Cypress, Karate)
- Our UI-level AI testing agent
- CI/CD integration and long-term maintenance of test suites
- Mobile device farm testing
Documentation
- Test strategies and test plans
- Traceability from requirement to result
- Documentation to FDA, MDR and other industry standards
- Evidence packages and validation reports
How we engage
- On-site
- Embedded in your team at your premises.
- Remote from Iași
- From our headquarters in Romania, using approved processes, our labs and structured communication.
How validation is delivered
- 01
Scope and risk alignment
We set testing depth by risk, criticality and the regulatory constraints that apply to the product.
- 02
Test strategy and management
Coverage mapping, environments, test data and acceptance criteria are agreed before execution starts.
- 03
Execution
Manual, automated and firmware testing, with AI agents where they add speed and consistency.
- 04
Quality gates
Internal gates aligned with MDR and FDA expectations check that traceability and evidence are complete.
- 05
Evidence and handover
Structured documentation and validation packages, ready for review and audit.
- of projects delivered on the planned timeline
- 100%
- shorter software verification with our automation
- 50%
What changes when it works
-
Clear release readiness
You know what has been verified and what is still open, at any point in the cycle.
-
Defects found earlier
Structured QA and quality gates catch problems before system test.
-
Repeatable releases
Automated suites and UI-level agents run the same checks every time.
-
Audit-ready evidence
Documentation organised the way auditors and notified bodies read it.
I have been working with Heaven Solutions for years in the field of quality assurance in medical device technology. Cooperation has always been characterized by trust, quality, and a high degree of flexibility. It is very reassuring to have a partner at your side who finds suitable and flexible solutions to changing project situations.
Teams we have built and tested software with
Tell us what you are building.
A 30-minute call with Cristian or Oana. We ask about your product, timeline and regulatory situation, and talk through how we could help.
Cristian Micliuc, CEO and founder
Oana Teslariu, Customer success, MedTech