Mantra Systems - We provide specialist EU MDR & UKCA Medical Device Regulatory Consulting Services.

We apply our medical expertise to the identification, analysis and production of clinical evidence, helping medical device manufacturers meet their obligations under the EU MDR and UKCA. Our unique approach to medical device regulatory consulting combines industry expertise with the key skills of clinically-active medical professionals.

Our core consulting services include:
- Clinical Evaluation with expert CER & CEP writing
- Systematic Literature Review data appraisal and analysis
- Clinical Evidence Generation through Post-Market Clinical Follow-Up (PMCF) Studies and Surveys

We also provide a selection of online EU MDR Training Courses, alongside downloadable EU MDR technical document templates and tools. These can be used with our regulatory compliant Document Management System, to give you an audit-ready solution for managing your own regulatory processes.