About CLIN-r+
Who We Are
CLIN-r+ was founded with a single objective in mind: “to ensure that patients have access to safe and effective medical devices and in vitro diagnostics.” To summarise, make sure that new device ideas are fit for purpose, always safe and effective.
CLIN-r+ is assisting manufacturers in the following clinical/regulatory and compliance areas to reach this goal:
- Under the IVDR, performance evaluation reports support.
- Clinical Evaluation Reports in Compliance with MDD/MDR Requirements
- Clinical data and peer-reviewed publications are generated to support the device’s safety and performance characteristics.
- Clinical and technical documentation (Risk/Biocompatibility/Usability/Technical) that is related to clinical documentation.
- Surveys and clinical experience data are planned and executed for PMCF requirements.
- Regulatory affairs expertise and support in management
CLIN-r+ are committed to assisting manufacturers in keeping compliant while assisting in overcoming the difficulty in bringing new technologies to the market.
As part of our growth, we now established the CLIN-r+ multi-disciplinary device rounds where expertise is gathered when writing Clinical Evaluations. CLIN-r+ has access to all medical specialties in UK and Europe to help manufacturers connect to end users and research networks to help develop technologies and do PMCF clinical data collection for the medical devices in use.
Due to continual research efforts, novel technology, disruptive innovation, market demands, and regulatory oversight, CLIN-r+ operates in a field that is naturally vibrant. As a result, we recognise that innovation is a multi-disciplinary process that extends far beyond a thorough understanding of technology.
The effective development of new, good ideas is the driving force behind CLIN-r+. By providing regulatory and compliance solutions that both our clients and ourselves require, we are committed to promoting a culture of transparency and educated action.
Patients’ demands for better care and a higher quality of life are a continual process that requires them to believe in the impossible and eliminate the unlikely. CLIN-r+ is committed to embarking on this path, to strive, to search, and to uncover solutions that will help society.
Case Studies
Have a look at our case studies how we have helped manufacturers tame and master their regulatory compliance:
Remediating biocompatibility workflows to meet EU MDR compliance requirements
Supporting an MDD to MDR transition
Fast Tracked PMCF Activities
Remediating a problematic Clinical Evaluation Report
