Regulatory affairs for diagnostics, medical devices and digital health

Regulatory inspections rarely fail because of a single issue. More often, findings reveal underlying weaknesses in documentation, procedures or quality oversight that have developed over time. Our MedTech regulatory Gap Analysis service identifies where those vulnerabilities exist, benchmarks them against current FDA, ISO 13485, EU/UK MDR and IVDR expectations, and provides a practical roadmap for remediation and inspection readiness.

FDA submissions are rarely just administrative exercises. The strongest medical device regulatory programmes are built around a clear understanding of regulatory expectations long before a submission is drafted. We support organisations throughout the process, from product qualification, product classification, regulatory pathway assessment, predicate device evaluation and Q-Submissions (pre-submissions) through to 510(k), De Novo and PMA submission preparation, FDA interactions and review support.

Obtaining CE Marking or UKCA certification is often straightforward in principle but challenging in practice. Questions around medical device classification for regulatory approval, evidence requirements and notified body expectations can quickly delay progress. We help manufacturers establish clear regulatory pathways and prepare the documentation needed to move products towards approval, drawing on proven expertise.

Expanding medical device sales into international markets requires coordinated regulatory planning across multiple territories. We support submissions and registrations across key global markets, including the US, EU, UK, Australia, Brazil and APAC regions, providing comprehensive support for FDA, CE, UKCA and over 90 territories globally.

Many manufacturers continue to face uncertainty under the Medical Devices Regulations (UK MDR 2002), EU MDR 2017/745 and the EU In Vitro Diagnostic Regulation 2017/746 (IVDR), whether developing a new device for market, transitioning legacy products, addressing documentation deficiencies or responding to notified body feedback. Our team provides hands-on support to help organisations maintain compliance, protect market access and navigate evolving market requirements under these regulations.

Product qualification and classification influence almost every subsequent regulatory decision, from evidence requirements and conformity assessment routes through to timelines and costs. Getting it wrong early can create significant delays later. We help manufacturers establish the appropriate classification and understand the implications for development, approval and commercialisation.

Maintaining compliance after market launch requires effective vigilance and Post-Market Surveillance (PMS) systems. We support complaint handling, Medical Device Reporting, vigilance reporting, recalls, PMS, PMCF, PMPF and corrective action activities, helping manufacturers meet regulatory obligations while protecting patient safety and maintaining market access.