Accelerating MedTech release cycles
High-velocity development without regulatory compromise. This is how we remove the bottleneck between a feature request and an EU- and FDA-compliant release.
Does this sound familiar?
Your feature backlog grows faster than your team can release, mostly because of the manual work needed to meet EU and US requirements. Engineers spend more time on traceability and documentation than on features.
“Our backlog keeps growing. By the time we validate one release, three more are waiting. Compliance work is consuming our best engineers.”
Backlog growing faster than releases
Features pile up while teams are locked in validation cycles and cannot ship at the pace the market expects.
Manual documentation
Engineers build traceability matrices, test reports and compliance evidence by hand, for every release.
Talent spent on repetition
Your best QA and development engineers do repetitive validation work instead of building what users need.
Two regulators at once
Meeting MDR or IVDR and FDA requirements at the same time multiplies the compliance work.
The regulatory speed trap
Between an idea and a release sit manual documents, traceability matrices, test evidence and compliance reviews. Without automation, this stage can consume 60 to 80% of the total release cycle.
- StartIdea or feature request
- BottleneckManual documents · traceability matrices · test evidence · compliance reviews
- EndMarket release
Lean R&D at regulatory speed
We replace manual heavy lifting with an automation toolchain, so your teams can move quickly without cutting corners on quality.
- 01
Integrated requirements engineering
Requirements are managed and traced automatically from the first request to final validation. A change propagates through the chain without anyone updating a matrix by hand.
- 02
Validated multi-level testing
Automation across the full test pyramid (unit, component API and end-to-end), so every release passes quality gates that meet the standards.
- 03
Autonomous AI agents
AI agents handle continuous, repetitive work such as reviews, builds and re-testing at night and at weekends, while your team is offline.
- 04
Human-centred engineering
With the routine work automated, your software, QA and requirements engineers spend their time on hard problems, architecture and features that matter.
A streamlined, automated pipeline that meets international standards and significantly shortens the time from change request to market release.
- EU MDR
- IVDR
- FDA
- IEC 62304
- ISO 13485
How we work with you
- 01
Discovery and assessment
We map your current development pipeline, find where time is lost in the regulatory cycle and document the as-is state.
- 02
Toolchain design
We design an automation toolchain for your stack and regulatory context, integrating requirements tools, test automation and AI agents into your existing workflow.
- 03
Implementation and validation
Our engineers work with your team to implement, configure and validate the new pipeline.
- 04
Continuous improvement
We monitor the pipeline and adjust it as your product and the regulatory requirements change.
Partnering with Heaven Solutions for software development, testing and engineering support on our medical device projects has been exceptional. Their flexibility and dedication ensured all deadlines were met, leading to multiple successful 510(k) and CE-marked releases. The team's friendly and respectful approach fostered a deep, trusting business relationship.
Stop letting compliance slow your releases.
We map your current release cycle together and look at how much time automation could recover.
Cristian Micliuc, CEO and founder
Oana Teslariu, Customer success, MedTech