Clinical Evaluation - pre-submission review

  • Get to market faster
  • Avoid costly delays or rejections
  • Gain certainty and confidence

Don't risk non-conformities - save time, money and worry through a professional pre-submission check.

What can you expect?

  • Expert Document Review: Our regulatory specialists will assess your EU MDR Clinical Evaluation documents to ensure they meet regulatory requirements.
  • Identify Gaps: We will highlight any areas for improvement to ensure regulatory compliance.
  • Actionable Report with Clear Guidance: You’ll receive a detailed, easy-to-understand report with actionable steps for making your documentation submission ready.

Why get your Clinical Evaluation documents reviewed?

  • Identify issues pre-submission: We will help you improve your documents, streamline your submission process, and accelerate time to market.
  • Save Time and Money: Avoid costly delays, revisions and re-submissions.
  • Expert Guidance: Our regulatory team will give you the confidence that your documentation meets MDR standards.

To reserve your pre-submission check, provide your details below and our team will be in touch.

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How Mantra Systems can support your Clinical Evaluation

What you get with Mantra Systems…

  • SOTA Literature Searches & Reviews
  • Clinical Data Appraisal & Analysis
  • Existing CER & CEP reviews
  • Experts in all types & classes of medical device
  • Personalised project plans to suit your needs
  • Named project lead to support you throughout
  • Flexible payment options with no hidden costs
  • Unlimited post-submission support until approval

Contact us today to talk with a Clinical Evaluation expert