Your Partner for MDR Compliant Clinical Evaluation Reports

Cut Costs by 20% with AI-Powered Solutions

Clinical Evaluation Report Challenges?

Managing clinical evaluation reports (CERs) while ensuring MDR compliance is tough. Our proprietary combination of AI-powered technology and specialized writing talent works together seamlessly to streamline the completion of MDR Compliant Clinical Evaluation Reports.

The End-to-End Solution for MDR Compliance

From initial assessments to ongoing maintenance, regulatory publishing is easier, more cost-efficient, and accurate with Celegence.

Our solution delivers:

Clinical Evaluation Reports MDR Compliance - High Quality

High-Quality and Timely Submissions

  • Expertise and Experience: With a team of clinicians, PhDs, and regulatory experts, we ensure that CERs and other PMS documentation such as PSURs and PMCF Plans are meticulously prepared and meet all regulatory standards.

  • First-Time Acceptance Rates: Celegence boasts a 99% first-time acceptance rate for submissions, minimizing the risk of costly delays and rework.

  • Comprehensive Services: From initial gap analysis to final submission, we handle every aspect of the regulatory process, ensuring timely and accurate compliance.

Efficient Resource Management - MDR Compliant Clinical Evaluation

Efficient Resource Management

  • Resource Augmentation: We provide flexible support, allowing companies to manage resource constraints and focus on core activities.
  • Ongoing Compliance Support: Continuous support ensures that feedback from Notified Bodies is incorporated into future updates, maintaining compliance over time.
  • Customized Solutions: Tailored strategies and consulting services help companies navigate complex regulatory landscapes without overburdening internal teams.
Cost Efficiency and Savings - Clinical Evaluation

Cost Efficiency and Savings

  • AI-Driven Solutions: We leverage AI and automation to streamline MDR compliance processes, reducing costs by up to 20%.
  • Scalable Support: By outsourcing to us, you can manage budget constraints more effectively, avoiding the high costs of in-house compliance teams.
  • Proven Track Record: We streamline processes and AI tools to consistently help clients save on compliance costs without compromising on quality.

What Our CER Clients Are Saying

Circle Cardiovascular Logo

“I want to thank your team for the valuable contribution and partnership during this project. It’s noteworthy to mention that the clinical assessment phase was passed the BSI assessment without any questions / additional information being asked. This is primarily the CER/CEP evaluation and risk assessment.Thank you the entire “Celegence Team” for the timely delivery of quality work which is continue to be accepted by EU Notified Bodies.”

Shirantha Samarappuli, PhD
Vice President, Regulatory Affairs & Quality Management Systems, Circle Cardiovascular Imaging

Zap Surgical - Testimonial Celegence

“I reached out to Celegence to help my company prepare for an upcoming MDR assessment for CE Certification in late April. The timeline was very short and the deliverables requested were substantial. We needed a rewrite of our Clinical Evaluation Report (CER) as well as a Gap Analysis of our Technical Documentation to the new EU MDR within 2 months. The feedback was very detailed and actionable allowing us to quickly address all deficiencies within a week.”

Jim Talbot
Vice President, RA/QA, Zap Surgical

Kavo Kerr Group - Clients Celegence Life Sciences

“The Celegence team has provided services to meet MDR compliance through high quality CERs in both a timely and cost-effective manner for our Medical Device portfolio. We look forward to a continued partnership in this compliance journey.”

Dr. Carlos Munoz-Viveros
Director, Clinical Affairs, KaVo Kerr

Our CER Process

Streamline your CER with a proven process.
Save on compliance costs without compromising the quality of your Clinical Evaluation Reports.

Initial Consultation
Understanding Your Needs

1. Schedule a free consultation to discuss your specific regulatory challenges and requirements.

2. Assess your current compliance status and identify areas needing improvement.

Customized Strategy
Tailored Compliance Plan

1. Develop a comprehensive, customized strategy leveraging AI-driven tools to address your unique needs.

2. Provide a detailed roadmap outlining steps to achieve full MDR compliance efficiently.

Implement & Documentation

Streamlined Execution

1. Execute the strategy with meticulous preparation and review of Clinical Evaluation Reports (CERs) and related documentation.

2. Utilize proprietary technology to ensure high-quality, timely CERs with a 99% first-time acceptance rate.

Ongoing Support
Continuous Compliance

1. Offer ongoing support to incorporate feedback from Notified Bodies and maintain compliance.

2. Regularly update and optimize your compliance processes to adapt to evolving regulatory requirements.

Resources to Assist Your Clinical Evaluation Report Knowledge

EU MDR IVA Compliance Technology - CAPTIS - Celegence
CAPTIS Brochure
EU MDR - Technical Documentation Checklist - Celegence
EU MDR Checklist
Download Medical Device Services Brochure Celegence
MEDICAL DEVICE BROCHURE
Contact Us Today

From consultative services to end-to-end CER writing capabilities, our expert team can support you in all aspects of your Clinical Evaluation. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.

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