Our Services
Clinical and regulatory support tailored to the needs of medical device companies at different stages of development and commercialisation.
Regulatory & Clinical Strategy Support
We support medical device companies in understanding and navigating applicable regulatory and clinical requirements, with a focus on structured decision-making and clarity.
Our involvement may include:
Discussion of regulatory pathways and applicable frameworks
Support in defining clinical and regulatory approaches
Input into planning activities aligned with MDR and relevant guidance
This service is particularly suited to early-stage companies or teams seeking experienced input when making key regulatory or clinical decisions.
Clinical Evaluation Support
We provide support across clinical evaluation activities in line with EU MDR and associated MDCG guidance, working collaboratively with your internal teams.
Support may include:
Clinical evaluation planning and approach definition
Literature review support and appraisal
Input into clinical evaluation documentation and updates
Our role is to support a structured, well-documented approach to clinical evaluation activities, appropriate to the device and its intended use.
Post-Market Clinical Follow-Up (PMCF) & Lifecycle Support
As devices progress through their lifecycle, ongoing post-market activities are essential. We support companies with post-market clinical and regulatory activities as requirements evolve.
This may include:
Support with PMCF planning and activities
Input into post-market updates and documentation
Ongoing regulatory and clinical support as devices change or scale
This service is designed to provide continuity and experienced input beyond initial conformity assessment stages.