Medical Device consultancy

Clinical evaluation support and workflow automation expertise to help manufacturers and economic players in complying with EU MDR and EU IVDR regulations.  

Clinical evaluation workflow right the first time. 

Clinical Evaluations for  EU MDR and CE marking

With experience in four notified bodies in CE marking and undergoing Clinical Evaluations audits we're cofindent in our expertise to help you get CEP, CER, PEP, PER, PMCF, PSUR, PMPF and PMCF plans right the first time.  

Regulatory expertise

Experience dealing with four notified bodies for MDD/IVD and MDR/IVDR compliance. 

IVDR and MDR compliant reports

Successful submission and audits of our clinical evaluation pathways and reports over various clinical specialities and four notified bodies. 

Workflow Automation 

Guiding businesses on automating their Clinical Evaluation and PMS workflows to reduce costs and improve efficiencies that ensures surveillance trending and Product Life Cycle compliance with MDR/IVDR regulations.  

Our work have been successfully reviewed by: 

Request your consultation today

IVDR/MDR workflow can be made efficient and easy to implement. As a manufacturer you might need quick remediation of your current CER's/PER's, so lets help you get it done.  Contact us today for a consultation how to align your RA strategy with your marketing strategy or remediate your current workflow to be compliant to MDR/IVDR with CLINR+.