Medical Device Regulatory Services
Bringing subject matter expertise to regulatory compliance
Clinical Evidence Generation
- PMCF studies & surveys
- GDPR-compliant data collection
- PMCF Plans & technical documents
- Clinical investigators & sites
Powerful PMCF systems designed by medical experts utilising pre-approved clinical investigators to generate high-quality clinical evidence for your medical device.
- Clinical Evaluation Reports & Plans
- Literature reviews & data analysis
- Notified Body engagement support
- Clinical Evaluation Reviews
Market-leading Clinical Evaluation and CER-writing services delivered by MDR-trained medical professionals with extensive data analysis and medical writing expertise.
- Clinically-active medical writers
- Subject Matter Experts
- MDR compliant documents & protocols
- Data analysis & literature reviews
Regulatory Medical Writing services designed for EU MDR compliance and delivered through the expertise of real medical professionals.
Clinical Investigators & Sites
Our database of pre-approved clinical sites and investigators means we can match your devices with motivated investigators interested in conducting PMCF studies.
Extensive database of clinical investigators
Pre-approved for PMCF studies
Rapid on-boarding & study initiation
Access to a broad range of clinical sites
MDR Training Academy
The Mantra Systems Academy is the complete MDR compliance support program. Integrating education, training, support, templates and full document management, it will empower your team to implement critical components of your MDR strategy without the need for outsourcing.
Quality Management *
Post-Market Surveillance *
* coming soon
How can we help you?
- Do you need a new regulatory partner?
- Are you starting from scratch?
- Or do you just need some advice?
Start by talking with us so we can fully understand your requirements.
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