All prices shown are indicative starting points. We provide fixed-scope quotations following an initial assessment of your regulatory position, device classification, and organisational requirements. Ad-hoc support is billed at a day rate agreed in advance.
Ongoing UK Responsible Person support for non-UK manufacturers placing devices on the Great Britain market under UK MDR. Includes regulatory representation, compliance oversight, documentation availability, and MHRA communication support.
EnquireEU MDR / IVDR Authorised Representative services for non-EU manufacturers. Includes regulatory representation within the EU, technical documentation coordination, and vigilance communication support. Final pricing depends on device classification and market scope.
EnquireRegulatory compliance oversight aligned with EU MDR requirements. Includes advisory support on compliance obligations, documentation review, and regulatory governance responsibilities.
EnquireStructured assessment of your Quality Management System against ISO 13485:2016 and EU MDR requirements. Includes identification of non-conformities, risk areas, and a prioritised remediation roadmap for audit readiness. Pricing varies based on organisational size and process complexity.
EnquireAssessment of technical files or design dossiers against EU MDR / IVDR requirements. Focuses on traceability (risk to design to verification), documentation completeness, and regulatory compliance gaps. Pricing depends on device classification and number of products under review.
EnquireDesign, implementation, or remediation of ISO 13485:2016 Quality Management Systems. Focused on audit readiness, process clarity, and inspection performance in real regulatory environments. Scope and duration vary by organisational size and current QMS maturity.
Request Scope AssessmentWe simplify and optimise quality processes before digitalisation to prevent system complexity, duplication, and audit inefficiencies. Ensures eQMS implementation aligns with real-world workflows rather than creating additional documentation burden.
Request Scope AssessmentFlexible on-demand support for urgent QA/RA needs including regulatory queries, audit preparation, CAPA support, documentation review, and Notified Body responses. Designed for short-term, high-priority regulatory issues where immediate expert input is required. Day rates are agreed in advance and confirmed in writing.
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