Mantra Systems
Regulatory consultancy supporting EU and UK market access for medical devices and in vitro diagnostics. Core services include clinical-evidence strategy and clinical evaluation report (CER/CEP) authoring, design and implementation of Post-Market Clinical Follow-up (PMCF) systems and registries, real-world evidence (RWE) assessment, regulatory assessment of software-as-a-medical-device (SaMD) including cybersecurity, technical documentation and quality management / PRRC advisory. The organisation provides document templates, online compliance tooling, a web-based natural-language regulatory guidance search, and supports systematic literature-search protocols and state-of-the-art (SOTA) reviews to support dossier preparation.
Industries
Nr. of Employees
small (1-50)
Products
Clinical evaluation report (CER) template (downloadable)
Comprehensive clinical evaluation report template with line-by-line guidance and illustrative examples to support CER authoring.
Web-based natural-language regulatory guidance search
Natural-language search interface for MDR and related guidance documents to retrieve relevant regulatory text and guidance snippets.
Clinical evaluation report (CER) template (downloadable)
Comprehensive clinical evaluation report template with line-by-line guidance and illustrative examples to support CER authoring.
Web-based natural-language regulatory guidance search
Natural-language search interface for MDR and related guidance documents to retrieve relevant regulatory text and guidance snippets.
Services
Regulatory strategy, technical-file preparation and submission support for EU MDR/IVDR and UKCA conformity across device risk classes.
Authoring of Clinical Evaluation Plans and Reports, literature searches, SOTA reviews and validation against MDCG expectations to support notified-body submissions.
Conduct protocol-compliant literature searches, screen and appraise evidence, apply structured weighting and prepare literature-review reports for inclusion in clinical evaluations.
Regulatory planning for in vitro diagnostic manufacturers to plan IVDR pathways, evidence strategies and documentation.
Design and implementation of prospective PMCF registries and clinical investigations, including eCRF selection, investigator onboarding, compliant remuneration frameworks and long-term data-collection planning.
Independent review of clinical evaluation and technical documentation prior to submission; gap analysis and remediation guidance to align dossiers with reviewer expectations.
Regulatory strategy, technical-file preparation and submission support for EU MDR/IVDR and UKCA conformity across device risk classes.
Authoring of Clinical Evaluation Plans and Reports, literature searches, SOTA reviews and validation against MDCG expectations to support notified-body submissions.
Conduct protocol-compliant literature searches, screen and appraise evidence, apply structured weighting and prepare literature-review reports for inclusion in clinical evaluations.
Regulatory planning for in vitro diagnostic manufacturers to plan IVDR pathways, evidence strategies and documentation.
Design and implementation of prospective PMCF registries and clinical investigations, including eCRF selection, investigator onboarding, compliant remuneration frameworks and long-term data-collection planning.
Independent review of clinical evaluation and technical documentation prior to submission; gap analysis and remediation guidance to align dossiers with reviewer expectations.
Expertise Areas
- EU MDR and IVDR regulatory compliance and UKCA strategy
- Clinical evaluation planning and CER/CEP development
- Systematic literature-search protocol development and SOTA review methodology
- Appraisal frameworks and evidence weighting for clinical evaluations
Key Technologies
- Systematic review methodologies (PICO, PRISMA)
- Scientific literature database searching (PubMed, EMBASE, Cochrane, Google Scholar)
- Protocol-driven literature search and SOTA review
- Structured appraisal frameworks and scoring systems
News & Updates
Webinar masterclass covering MDR overview, evidence generation and regulatory systems to MDR standard.
Participation and attendance at MEDICA events to engage with industry stakeholders.
Explains why legacy and other devices may require Post-Market Clinical Follow-up under the EU MDR, criteria for exemptions and appropriate PMCF design proportional to device risk.
Discussion of emergency derogation procedures and expedited conformity-assessment options available during public-health emergencies and the balance between product availability and safety.
Argument that medically trained personnel are well placed to appraise clinical evidence, support PMCF and clinical-evidence activities, and improve regulatory objectivity.
Overview of RWE methods, assessment of registries and commercial datasets, and rationale for prospective PMCF systems for regulatory submissions.
Webinar masterclass covering MDR overview, evidence generation and regulatory systems to MDR standard.
Participation and attendance at MEDICA events to engage with industry stakeholders.
Explains why legacy and other devices may require Post-Market Clinical Follow-up under the EU MDR, criteria for exemptions and appropriate PMCF design proportional to device risk.
Discussion of emergency derogation procedures and expedited conformity-assessment options available during public-health emergencies and the balance between product availability and safety.
Argument that medically trained personnel are well placed to appraise clinical evidence, support PMCF and clinical-evidence activities, and improve regulatory objectivity.
Overview of RWE methods, assessment of registries and commercial datasets, and rationale for prospective PMCF systems for regulatory submissions.