Medical devices
New registrations, dossier changes and lifecycle support. We work with IVDs and software as a medical device, including AI-based solutions.
Classification and regulatory route
We assess device type, potential risk class, composition, components, models and variants.
- Quality system, inspection and post-registration monitoring requirements.
- The scope of laboratory, toxicological and other testing.
- The need for human clinical trials or an assessment of existing clinical evidence.
- Selection of standards and their scope; clarification from authorities or expert organisations where needed.
Documentation and testing
We adapt manufacturer documents or develop them from the beginning, and select laboratories for the required work and accreditation scope.
- Technical and operating documentation.
- Test planning and coordination, oversight and review of results.
- Preparation of clinical evaluations from existing data and literature, with review and signature by the clinical centre.
Clinical trials and post-registration monitoring
We prepare the documentation and analytical work for clinical trials, with medical centres acting as study sites.
- The complete package, from programme or protocol to final report.
- Study oversight, data management and biostatistics.
- Post-registration clinical monitoring: planning, work with healthcare institutions, implementation and reporting.
- For AI solutions, design justification and complex sample size calculations, also available separately.
Quality systems and inspections
We support the implementation and improvement of manufacturer quality systems, inspection readiness and follow-up.
- Pre-inspection audits.
- Documentation and process preparation.
- Manufacturing inspection support.
Dossier changes and authorised representation
For dossier changes, we assess the applicable framework, need for expert review and feasibility given the current dossier.
- Assessment and preparation of the required documents.
- Manufacturer authorised representative services covering the full set of applicable legal obligations.
- Scope and responsibilities agreed at the start of the project.
How we can support you
An individual document, study, project stage or complete programme. We agree source data, deliverables, timelines and responsibilities before work begins.
Where do we start?
Tell us about your product and objective. We will assess the available information, identify what is needed and agree the right scope of work.