CLINICAL EVIDENCE
Product evaluations/case studies
Product evaluations by clinicians considering your product for inclusion on their formulary can be a rich source of ‘real-life’ evidence for your marketing as well as Post-Market Surveillance.
They need to be well-structured and managed by people with the appropriate skills. We can support your teams internationally in the design and management of evaluations to make the most of this opportunity.
Post-Market Surveillance
Post-market surveillance (PMS) is vital to the regulatory framework for medical devices. The emphasis on gathering clinical and safety related data after the product has been approved is more significant to the product lifecycle than ever.
The Medical Device Regulation (MDR) (Art 2 (60)) defines post-market surveillance that allows the identification of problems with the design, manufacture or use of the product.
The process of continuously updating the clinical evaluation with data ultimately enhances patient safety. We offer a range of services that allow you to monitor and capture data once your product has been launched.
Post-Market Clinical Studies
Collecting data from multiple sources and cross market populations can prove to be a challenge and time consuming. Our experience and expertise coupled with our international reach can deliver post market studies that help you realise your products’ full potential and allow you to make crucial decisions for the product lifecycle.
Medical Writing for Publication
We can provide medical writing for an array of publications and our medical writers are experienced clinicians and medical writers from the wound care industry.