Our Toolkits and Templates provide pre-structured, regulator-aligned documentation frameworks that accelerate MDR, IVDR, and ISO 13485 compliance implementation. We deliver customisable, audit-ready materials that standardise processes, reduce administrative burden, and enhance documentation quality.

Our Workshops provide targeted, expert-led training that strengthens internal capability across regulatory, quality, and compliance functions. We translate complex MDR, IVDR, and quality system requirements into practical, actionable understanding for teams at every organisational level.

Our Artificial Intelligence (AI) in Medical Devices services support compliance with MDR, IVDR, and the forthcoming EU Artificial Intelligence Act. We design governance and documentation frameworks that enable transparent, ethical, and regulator-ready AI solutions for healthcare applications.

Our Compliance services for Software as a Medical Device (SaMD), ensure alignment with MDR, IVDR, and IEC 62304 requirements. We provide complete regulatory frameworks for software development, validation, and lifecycle management that support safe, compliant, and scalable innovation.

Our Labelling Compliance services ensure that all device labels, packaging, and Instructions for Use (IFU) meet MDR and IVDR requirements. We establish clear, compliant labelling frameworks that integrate regulatory precision, linguistic accuracy, and operational control.

Our Design Dossier Update services ensure that legacy and new device documentation remains current, compliant, and aligned with evolving MDR and IVDR expectations. We manage updates systematically to preserve traceability, integrity, and certification continuity.

Our Technical Documentation Creation and Remediation services ensure complete, coherent, and audit-ready files that meet MDR and IVDR Annex II and III requirements. We structure documentation to demonstrate conformity, consistency, and traceability across the product lifecycle.

Our Fractional Regulatory Affairs and Quality Assurance (RA/QA) services provide flexible access to senior expertise without permanent headcount. We deliver strategic oversight, compliance management, and operational execution to sustain MDR and IVDR compliance cost-effectively.

Our Audit Preparation services ensure readiness for Notified Body, Competent Authority, and internal audits under MDR, IVDR, and ISO 13485. We establish the documentation, processes, and team capability required to achieve successful inspection outcomes.

Our Post-Market Surveillance and Vigilance services establish comprehensive systems that meet MDR and IVDR requirements for continuous safety monitoring. We integrate evidence generation, signal management, and regulatory reporting to sustain compliance and product trust throughout the lifecycle.

Our Economic Operator Support services ensure full alignment with MDR and IVDR requirements across manufacturers, authorised representatives, importers, and distributors. We establish compliant roles, contracts, and oversight frameworks that safeguard market access and regulatory accountability.

Our EUDAMED and Unique Device Identification (UDI) services establish robust data governance, submission, and maintenance processes that ensure full MDR and IVDR compliance. We enable accurate, audit-ready registrations that scale across product portfolios and European markets.

Our Notified Body Readiness services ensure that your organisation is fully prepared for MDR and IVDR conformity assessments. We align documentation, quality systems, and personnel readiness to Notified Body expectations, minimising non-conformities, shortening review timelines, and safeguarding certification outcomes.

Our Regulatory Strategy services enable medical device companies to navigate complex MDR and IVDR requirements with clarity and confidence. We design structured, evidence-based pathways that accelerate conformity assessment, mitigate regulatory risk, and align compliance objectives with commercial goals.