Structure and traceability for regulated product delivery
Clear links between requirements, risks, tests and release decisions. Quality processes with named owners and review gates. Evidence that is ready before the audit. We set this up with your team and help keep it running.
What governance covers
Built around compliance, quality systems and risk control, across the whole product lifecycle.
Regulatory compliance
- EU MDR and FDA compliance
- IEC 62304 software lifecycle
- ISO 13485 alignment
Quality management
- Quality management system structure, controls and improvement
- Process and lifecycle governance, change control
- Business analysis and documentation
Audits and risk
- Gap analysis and audit preparation
- Cybersecurity and risk assessments
- Evidence packages and review cycles
AI governance
- Governance, security and compliance built into AI development
- Validation of AI-based tools used in regulated processes
How governance is applied
- 01
Regulatory and risk context
We identify the applicable standards (MDR, FDA, IEC 62304, ISO 13485), the criticality of the system and the main delivery risks.
- 02
Framework definition
QMS structure, roles, decision points, documentation standards and quality gates that fit your organisation.
- 03
Implementation and oversight
Governance becomes part of daily delivery through controlled workflows, reviews and clear expectations for evidence.
- 04
Audit preparation
Internal assessments, gap reviews and traceable evidence packages keep you ready between audits.
- 05
Continuous improvement
We adjust processes and controls based on findings, delivery feedback and changing regulation.
What changes when it works
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Lower compliance risk
Structured controls and traceability aligned with MDR and FDA expectations.
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Smoother audits
Evidence organised for reviews, audits and assessments.
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Fewer late surprises
Quality gates catch gaps before they turn into rework.
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Visibility for management
Reporting and decision logs that keep stakeholders aligned.
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.
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