Long-running clinical evaluation and medical writing programmes, with the delivery figures we track.
Technical documentation, submissions and registrations prepared to hold up at review.
Legacy technical documentation was not consistently aligned with current MDR requirements.
Client contextAn established manufacturer preparing a Notified Body review
Converting an incomplete regulatory evidence set into a structured submission.
Client contextA manufacturer planning entry into the United States
Addressing gaps between legacy documentation and IVDR evidence expectations.
Client contextAn IVD manufacturer updating its EU compliance strategy
Standardising evidence for parallel international registration activities.
Client contextA manufacturer expanding into multiple regulatory jurisdictions
Quality systems, CAPA, risk management and design controls brought back under control and made auditable.
Modernising a fragmented quality system for harmonised compliance.
Client contextA medical device organisation strengthening its quality framework
Converting audit observations into documented, sustainable corrective action.
Client contextA regulated manufacturer addressing external-audit findings
Re-establishing consistency across hazards, risk controls and downstream records.
Client contextA manufacturer with an evolving product portfolio
Restoring a controlled design history following successive product changes.
Client contextA medical device manufacturer with legacy design records
Clinical evaluation, literature reviews, PMCF and IVD performance evidence that reviewers can trace.
Building a defensible clinical evidence narrative from disparate data.
Client contextA manufacturer maintaining EU regulatory compliance
Creating reproducible clinical evidence packages across therapeutic areas.
Client contextA manufacturer requiring recurring literature documentation
Strengthening the lifecycle link between clinical evaluation and post-market evidence.
Client contextA manufacturer updating its clinical follow-up approach
Integrating scientific, analytical and clinical performance assessments.
Client contextAn IVD organisation updating its performance evidence
PSURs, complaint handling, vigilance and the feedback loop into the risk and clinical files.
Transforming dispersed post-market inputs into a defensible PSUR.
Client contextA manufacturer with an established European device portfolio
Strengthening complaint consistency from intake through closure.
Client contextA manufacturer operating across multiple markets
Harmonising safety-event assessment for multiple regulatory markets.
Client contextAn international medical device organisation
Connecting recurring surveillance reviews with product lifecycle decisions.
Client contextA manufacturer improving post-market governance
Engagements are anonymised and client names are withheld. Outcomes are described qualitatively unless figures are given. Documents described here were prepared by our specialists; regulatory and certification decisions remain with the authorities and Notified Bodies concerned.
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.
