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.
As such, RNI has grown into a dedicated and reliable partner with a proven track record in helping companies achieve medical device CE and UKCA marking for all classifications.
By partnering with RNI for medical device projects, you will get access to our regulatory, quality, clinical and toxicological experts covering the full scope of product development.
Our medical device services include:
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.
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