Category 01
Market Access &
Regulatory Representation
UK Responsible Person (UKRP)
Regulatory representation for non-UK manufacturers placing medical devices on the Great Britain market under UK MDR. We ensure correct regulatory representation, documentation control, and MHRA alignment for market entry and ongoing compliance.
EU Authorised Representative (EU Rep)
Regulatory representation for non-EU manufacturers under EU MDR and IVDR. We act as your compliance interface within the EU, ensuring technical documentation availability, vigilance handling, and regulatory authority communication.
Notified Body Selection Support
Strategic support in selecting the most appropriate Notified Body based on device classification, regulatory scope, timelines, and approval risk. We help reduce certification delays and improve approval success probability through informed NB selection strategy.
Category 02
Quality & Regulatory
Compliance Systems
EU MDR / IVDR Compliance Readiness
End-to-end regulatory strategy for EU MDR and IVDR compliance. Includes technical documentation structure, gap analysis against regulatory requirements, and full submission readiness assessment. Covering Class I through Class III medical devices and all IVD categories.
ISO 13485 Quality Management Systems
Design, implementation, and remediation of ISO 13485:2016-compliant quality management systems. Focused on audit readiness, process clarity, and real-world inspection performance — not just procedural paperwork compliance.
PRRC Support
Provision of PRRC support under EU MDR requirements, ensuring regulatory accountability, compliance oversight, and technical documentation integrity. Suitable for manufacturers requiring designated PRRC resource without full-time headcount.
Category 03
Quality System
Optimisation & Digitalisation
eQMS Simplification & Implementation
We simplify and optimise quality processes before digitalisation to avoid system complexity, duplication of workflows, and audit inefficiencies during eQMS implementation. Real process improvement first — then the right technology to support it.
CAPA & PMS System Design
Design and optimisation of Corrective and Preventive Action (CAPA) and Post-Market Surveillance (PMS) systems aligned with EU MDR regulatory expectations and Notified Body audit requirements. Systematic, proportionate, and inspection-ready.
Ad-hoc Regulatory & Quality Support
Flexible 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.