MedStride provides full-lifecycle MDR and UKCA support – from early regulatory strategy and documentation planning to certification, post-market surveillance, and ongoing compliance. Our focus is to give you clear, actionable steps at every stage.
Defining the appropriate regulatory pathway, aligning requirements with business goals, and creating a structured plan that supports efficient approval and sustained compliance.
Developing MDR-aligned Clinical Evaluation Plans and Reports, including PMCF and surveillance documentation, to ensure clinical evidence meets regulatory expectations.
Preparing complete and compliant technical documentation to support smooth MDR and UKCA certification and reduce delays during conformity assessment.
Identifying compliance gaps and developing practical remediation plans to meet regulatory requirements and prepare your device for certification and market access.
Preparing and structuring regulatory submission files with accurate, complete documentation to support smooth and efficient approval processes.
Establishing and maintaining post-market surveillance and quality systems to ensure ongoing compliance, continuous market access, and alignment with evolving regulatory expectations.
Providing R&D support across device development, including feasibility planning, early testing, and engineering guidance to advance concepts toward regulatory-ready solutions.
Coordinating verification and validation activities, including biological safety evaluation, usability studies, and preclinical testing to meet regulatory requirements.
Delivering tailored training on regulations, harmonised standards, and best practices to equip teams with practical, compliance-ready knowledge.
We’re your dedicated partner in success, offering expertise and personalized support every step of the way.
Innovation thrives on persistence. Let’s work together to refine your approach and achieve exceptional results.
Support covers a wide range of medical devices, from early-stage concepts to market-ready products, across all risk classes and categories.
Yes. Services include determining the appropriate conformity assessment pathway and mapping the regulatory steps required for certification.
Yes. we work with you to prepare Clinical Evaluation Plans (CEP), Reports (CER), PMCF plans, PMCF reports, and surveillance documentation.
Submission support includes structuring, preparing, and reviewing technical files, MDR and UKCA submissions, and ensuring they meet Notified/Approved Body expectations.
Services include PMS planning, PMCF activities, vigilance reporting, and ensuring ongoing compliance and continuous market access.
Yes. R&D support includes feasibility planning, early testing, engineering guidance, and preparing concepts for regulatory-ready development.
Gap analysis services assess your current documentation, QMS, and technical evidence to highlight deficiencies and provide clear remediation actions.
Yes. Tailored training and workshops help teams understand MDR, UKCA, harmonised standards, and best practices for maintaining regulatory compliance.
Book a short call and we’ll clarify your regulatory priorities.
