Ensure Regulatory Compliance with Clinical Evaluation Report (CER) Preparation
Streamlined Clinical Evaluation for Regulatory Success
A well-prepared Clinical Evaluation Report (CER)
We provide expert support in clinical data collection, literature reviews, post-market clinical follow-up (PMCF), and real-world data analysis.
Regulatory CER Expertise
Comprehensive Data Analysis
Seamless Audit Preparation
How does this work?
Clinical Data Collection & Review
Conduct systematic literature searches and analyze clinical data for regulatory submissions.
Post-Market Surveillance & PMCF
Implement PMCF strategies and real-world data analysis for continuous compliance.
Audit & Compliance Support
Prepare for clinical audits, ensuring readiness for regulatory inspections.
Comprehensive Clinical Evaluation Report (CER) Preparation
Preparing a comprehensive Clinical Evaluation Report (CER) is essential for regulatory submissions.
We offer expert support in developing CERs to meet regulatory requirements, ensuring your reports are detailed and compliant.
Standards:
- EU MDR
- MEDDEV 2.7/1 Rev 4
Services:
- Clinical data collection
- Literature review
- CER drafting and submission
Compliance Roadmap Tailored to Device-Specific Requirements
Creating a compliance roadmap tailored to your medical device’s unique requirements is crucial for regulatory success.
Our customized roadmaps outline essential steps and milestones for achieving regulatory approval.
Our approach ensures a clear, actionable path to compliance, helping you avoid delays and meet all regulatory expectations.
Services:
- Initial Gap Assessment
- Compliance Strategy Development
- Ongoing Regulatory Updates
Literature Search and Data Analysis
Conducting thorough literature searches and data analysis is critical for supporting regulatory submissions and product development.
We provide expert support in gathering and analyzing relevant data, enhancing your regulatory submissions and product development.
Services:
- Systematic literature reviews
- Data extraction and analysis
- Comprehensive reporting
Effective Post-Market Clinical Follow-Up (PMCF) Strategies
Post-market clinical follow-up (PMCF) is essential for monitoring the safety and performance of your medical devices.
We develop and implement effective PMCF strategies to ensure ongoing compliance and product safety.
Regulations:
- EU MDR
- ISO 14155
Services:
- PMCF planning and execution
- Data collection and analysis
- Regulatory reporting
Comprehensive Real-World Data Collection and Analysis
Collecting and analyzing real-world data is crucial for understanding the performance and safety of your medical devices post-market.
We offer comprehensive support for real-world data collection and analysis, utilizing real-world data to enhance your post-market surveillance and regulatory compliance.
Standards:
- ISO 14155: Clinical investigation, Good Clinical Practice (GCP)
Services:
- Data collection protocols
- Real-world evidence (RWE) analysis
- Reporting and interpretation
Achieve Compliance with Clinical Investigation Regulations
Ensuring compliance with clinical investigation regulations is critical for the successful development of your medical devices.
We provide expert guidance to navigate the regulatory requirements, helping you achieve compliance with clinical investigation regulations.
Standards
- EU MDR
- FDA Investigational Device Exemption (IDE)
- ISO 14155
Services
- Clinical investigation planning
- Regulatory submissions
- Monitoring and reporting
Expert Preparation for Clinical Audits
Preparing for clinical audits is essential to ensure your compliance with regulatory requirements.
Our team provides comprehensive support to help you prepare for and manage clinical audits, ensuring successful outcomes.
Services:
- Audit planning
- Document preparation
- Audit readiness assessments
Reach out to us and ensure Regulatory Compliance with Clinical Evaluation Report (CER) Preparation
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