Medical Device Regulatory Consulting
Bringing subject matter expertise to Medical Device Regulatory Consulting
Medical Device Regulatory Services
Our team of MDR consultants are medical device regulatory specialists offering tailored MDR compliance services.
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PMCF Plans, Studies & Surveys
Powerful medical device PMCF Plans, Studies & Surveys designed by medical experts and driven by leading-edge eCRF, ePRO and data storage systems.
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Clinical Evaluation
Market-leading Clinical Evaluation and CER-writing services delivered by MDR-trained medical professionals with extensive data analysis and medical writing expertise.
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Medical Device Software
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.
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Medical & Technical Writing
Specialist Medical & Technical Writing services designed for MDR compliance and delivered through the expertise of real medical professionals.
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Systematic Literature Reviews
Identification, appraisal and analysis of medical device clinical evidence conducted by professional medical experts and refined for MDR compliance.
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Personalised Support
Receive tailored and personalised MDR consulting support through dedicated access to our team of expert medical professionals.
How can we help you?
- Do you need a new regulatory partner?
- Are you starting from scratch?
- Or do you just need some advice?