The greatest compliance risks are no longer limited to clinical evaluation or technical documentation. Cybersecurity, AI governance and continuous lifecycle monitoring are moving higher up the agenda of notified bodies, competent authorities and customers.
But we still regularly see that:
- Cybersecurity is not sufficiently integrated into risk management
- Technical documentation contains limited digital safety evidence
- PMS processes are not designed to address newly identified vulnerabilities
- Regulatory, quality and development teams are not fully aligned
The results? Delays in certification, additional questions during audits and unnecessary risks to market access.
At Starodub B.V. we help medical device manufacturers proactively address these challenges through:
- MDR/IVDR gap assessments
- SaMD and digital health solutions
- Technical documentation and dossier reviews
- Regulatory strategy and notified body support
- PMS, PMCF and QMS optimization
We combine regulatory expertise, quality management and practical execution to turn compliance into a competitive advantage.
The question is not whether digital safety is part of your compliance strategy. The question is whether you can demonstrate today that you have it under control.
Curious where the greatest risks in your MDR or IVDR pathway may lie? Let’s connect.
See our website or www.starodub.nl or contact us directly via info@starodub.nl
