The medical device landscape in Europe and the UK continues to be attractive for manufacturers looking to develop new products or to reclassify an existing product.
Feasibility assessments: how to position your product, the level of scientific and clinical data required, regulatory and quality considerations specific for you
CE mark and UKCA mark strategic planning: gap analysis and reverse planning to meet your commercial deadlines
Product classification: working with the latest guidelines and opinions to justify medical device status and classification
Clinical evaluation reports: full service to write or update reports
Biological evaluation reports: full service toxicological risk assessments and report writing
Usability / human factors advice: formative and summative test planning, guidance, risk assessments and reports
Full technical file creation: organisation of data and writing the full technical file for all classes of medical devices
Post marketing: PMS, PMCF plans and reports, and materiovigilance handling
Quality management system: implementation and auditing
Risk assessments: implementation and auditing
Validation of all forms of communication including claims, labelling, advertising etc.