We'll get you first-time approval & compliance for your medical devices
With a 100% CER submission success rate under the UK & EU MDR, our team of over 50 medical writers are specialists in handling large projects producing multiple CERs & CEPs in parallel.
Literature search, review and analysis of medical device clinical evidence conducted by medically-trained subject matter experts and refined for regulatory compliance.
Comprehensive design & management of PMCF studies utilising pre-approved clinical investigators to generate high-quality clinical evidence for any class of medical device.
SSCPs from TOPRA-registered medical device regulatory specialists and clinicians who are experts in writing for professional and lay audiences.
Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the services again in the future should the need for further support arise.
PWHead of Clinical Governance & Regulatory Affairs Manufacturer, UK
It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.
JFChief Executive Officer SaMD Company, Denmark
