Services
Successfully navigate compliance with confidence throughout the complete medical-device lifecycle.
Build the regulatory pathway, evidence, software lifecycle, and management systems required before market access.
When developing digital healthcare solutions, regulations and standards can feel complex. A strong regulatory strategy helps identify the most efficient pathway while ensuring every requirement is met with clarity.
Learn More
As healthcare data becomes more digital, real-time threats to digital health solutions increase. A robust cybersecurity and privacy framework protects data, supports compliance, and strengthens trust in daily usage.
Learn More
Digital healthcare solutions rely on personal health data across development, testing, and use. We help organisations build clear procedures and documentation that meet security, privacy, and governance requirements.
Learn More
Digital healthcare solutions, such as SaMD, SaIVD and High-Risk AI systems, evolve after launch with new features, model updates, and patches. We support SaMD and SaIVD compliance, and manage each change through regulatory, clinical, and quality oversight.
Learn More
Management systems support quality, AI and information security needs, including ISO 13485, MDSAP, ISO/IEC 42001, EN 18286, ISO/IEC 27001 and NEN 7510-1. We help implement them with practical procedures and records.
Learn More
Bringing digital healthcare solutions to new markets adds regulators, classification rules, evidence expectations, and local representation duties. We help teams manage regional requirements with clear documentation.
Learn MoreMaintain compliant products, registrations, operators, oversight, and evidence once devices are on the market.
Regulatory compliance extends beyond the manufacturer to importers, distributors, authorised representatives, repackers, and relabelers. We help define and document each operator’s duties across the full supply chain
Learn More
If EUDAMED or GUDID registrations are difficult to manage, our secure, in-house MDIS solution helps you complete and maintain UDI registrations with structured data, traceability, and regulatory support and review.
Learn More
Audits can cover internal processes, suppliers, due diligence, FDA mock readiness, MDR / IVDR quality systems, ISO 13485, ISO/IEC 27001, and NEN 7510-1. Our auditors execute audits and support external audit reviews.
Learn More
Once a digital healthcare solution is on the market, post-market data may reveal valuable insights, including unexpected adverse events. We support assessment, documentation, and reporting to regulatory authorities.
Learn More
We provide interim support for key roles, including DPO, PRRC, and quality, regulatory, and information security experts. This helps maintain oversight, continuity, and compliance where specialist capacity is needed.
Learn More
Healthcare software deals depend on what diligence finds or misses. We assess regulatory exposure, classification, documentation, and post-market duties so risks are clear before acquisitions or investments close.
Learn More