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MDR Guidance Resources
Our unique MDR Guidance Resources are written by our medical experts and cover all aspects of the new Medical Device Regulation.
MDR Consulting Services
Our team of MDR-trained healthcare professionals are specialists offering tailored Medical Device Regulatory Consulting Services.
Powerful medical device PMCF Plans, Studies & Surveys designed by medical experts and driven by leading-edge eCRF, ePRO and data storage systems.
Market-leading Clinical Evaluation and CER-writing services delivered by MDR-trained medical professionals with extensive data analysis and medical writing expertise.
Special SaMD applications of our PMCF, Clinical Evaluation, Medical Writing and Evidence Generation services address the unique challenges of applying MDR requirements to medical software.
Specialist Medical & Technical Writing services designed for MDR compliance and delivered through the expertise of real medical professionals.
Identification, appraisal and analysis of medical device clinical evidence conducted by professional medical experts and refined for MDR compliance.
MDR Training Academy
Our MDR Training Academy runs events delivered by our experts and address all aspects of MDR compliance.
Learn how to integrate our medical experts clinical knowledge into your MDR compliance strategy.
Our online workshops are designed to quickly and effectively fill gaps in your MDR knowledge-base.
Learn all aspects of the MDR and its application to regulatory approval of your medical devices.
Keep up to date with our thoughts on the industry. All our articles
Is outside consulting support the answer to your MDR transition?
Getting ready for the MDR is a demanding process. Outsourcing might be your solution.
Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
Simplifying the challenges posed by the new EU MDR
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the EU MDR.