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Clinical Evaluation Report (CER) Writing Services

Expert CER preparation for medical device manufacturers to ensure compliance with MDR 2017/745 and global regulatory requirements

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What is a Clinical Evaluation Report (CER)?

A crucial document required by the European Medical Device Regulation (MDR 2017/745) demonstrating your device's safety and performance

Why Choose Our CER Writing Services?

In today's stringent regulatory environment, a well-prepared CER is critical to gaining and maintaining market access for medical devices.

  • Expert team of medical writers and regulatory specialists
  • Comprehensive literature search and data analysis
  • Customized CERs for all medical device classes
  • Full compliance with MDR and MEDDEV guidelines
  • PMCF integration for ongoing compliance
  • Timely delivery with strict confidentiality

Our CER Writing Process

A structured, efficient approach to CER development

Initial Consultation

Gathering device information and documentation requirements

Clinical Data Evaluation

Review of preclinical studies, clinical trials, and post-market data

Benefit-Risk Analysis

Comprehensive assessment of device advantages vs potential risks

CER Drafting & Review

Preparing the report with rigorous quality checks

Final Submission

Delivery of compliant CER ready for regulatory submission

Key Components of a High-Quality CER

We ensure each CER includes all essential elements required by regulatory authorities:

  • Clinical background and device description
  • Comprehensive literature review and data analysis
  • Detailed benefit-risk assessment
  • Post-Market Clinical Follow-Up (PMCF) plan
  • Conformity assessment with MDR requirements
  • State-of-the-art review and clinical conclusions

Who Can Benefit from Our CER Services?

Comprehensive support for all stakeholders in medical device regulation

Medical Device Manufacturers

For new device launches or maintaining compliance of existing products

Regulatory Affairs Teams

Expert support to lighten your regulatory burden

Notified Bodies

Well-structured CERs that facilitate smooth review processes

Stay compliant with evolving MDR requirements with our expert CER services

Request CER Consultation
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