Clinical Evaluation

Medical device CERs, CEPs, literature reviews & data analysis by clinically-active medical experts

An effective medical device Clinical Evaluation requires a detailed analysis of clinical evidence generated from multiple sources.

EU MDR-compliant medical device Clinical Evaluation

  1. Clinical Evaluation Reports (CERs) & Clinical Evaluation Plans (CEPs) produced by MDR-trained medical writers.
  2. Systematic literature reviews & data analysis forming the core of compliant Clinical Evaluation.
  3. Ongoing Notified Body engagement support to address any queries and feedback after CER submission.
  4. Adherence to MDR standards for all device classes according to MDR Annex XIV, MEDDEV & MDCG Guidelines.
  5. Collaborative proposals with transparent, fixed-cost pricing to reflect the unique needs of your medical device.

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What our clients say

We engaged the services of Mantra Systems to support us with updating our Clinical Evaluation Reports both for MDR (UK) and MDR (EU). From start to finish the engagement and communication has been proactive and timely, keeping us updated throughout the entire process, and the quality of the reports fully met our needs.

Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the CER services again in the future should the need for further support arise.

PW

Head of Clinical Governance & Regulatory Affairs Medical Device Manufacturer, UK

Clinical Evaluation Reviews

If you have an existing Clinical Evaluation strategy, we can also review this and produce a comprehensive report with guidance and advice.

  • Identification of any gaps in your Clinical Evaluation approach

  • Direct analysis on your CERs from our clinically-active writing team

  • Help & support on Notified Body engagement

  • Feedback from subject-matter experts that have used your medical device

Please contact a member of our team to discuss this service in more detail.

Start today

Our specialist team will apply their medical writing and subject matter expertise to produce your regulatory compliant Clinical Evaluation.

Start by talking with us so we can fully understand your requirements.

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