Mapping the full route to market across every jurisdiction, and the submissions that carry your product through it.
Creation, review, and maintenance of high-quality technical documentation aligned with current regulations.
Design and execution of clinical evaluations and performance studies to demonstrate safety and effectiveness.
Comprehensive risk management throughout the product lifecycle, from design through post-market.
Build and manage PMS and vigilance systems to ensure ongoing compliance and product safety.
Quality management system design, implementation, remediation, and continuous improvement.
Internal audits, supplier audits, and gap assessments to ensure compliance and readiness.
Support for electrical safety, EMC testing, and compliance with relevant standards.
Expertise in software development lifecycle (SDLC), SaMD regulatory compliance and cybersecurity
considerations.
Tailored training programmes on regulatory and technical topics for your teams.
Development of robust procedures and efficient processes to support compliance and scalability.
UKRP, EU AR, Swiss CH-REP, and appointed representation across the US, Australia and India, delivered through our group and partner network. Medical, IVD, PPE and radio equipment each carry their own obligations — we make sure none are missed.
Your Person Responsible for Regulatory Compliance under Article 15 of the MDR and IVDR, and the equivalent under the Swiss MedDO and IvDO. The qualified, named person the Regulations require you to have permanently and continuously at your disposal and to declare in EUDAMED and swissdamed — provided as a service, without the headcount.
Liaison with competent authorities and notified bodies, and advocacy for your interests through review, questions, and approvals.
Whether you are navigating a specific regulatory challenge or seeking strategic guidance, we welcome the opportunity to discuss how we can help.
