Are you struggling with creating compliant and comprehensive Clinical Evaluation Reports for your medical devices? Our CER writing experts are ready to help.
Why Choose Our Clinical Evaluation Report Writing Services
When it comes to Clinical Evaluation Reports, quality and compliance are non-negotiable. Here’s why our services stand out:
Experienced Medical Device and Healthcare Writers:
Our team consists of professionals with extensive experience in the medical device industry.
MDR and MEDDEV 2.7.1 Rev 4 Compliant Reports
We stay up-to-date with the latest regulatory requirements to ensure your CERs meet all necessary standards.
Customized CERs for Various Medical Devices
Whether you’re dealing with Class I, II, or III devices, we tailor our reports to your specific needs.
Affordable Pricing with Quick Turnaround
Get high-quality reports without breaking the bank or missing deadlines.
Types of Clinical Evaluation Reports We Offer
Our services cover a wide range of clinical evaluation reports:
Medical Device CERs
EU MDR Clinical Evaluation Reports
MEDDEV 2.7.1 Rev 4 Compliant Reports
Clinical Study Reports (CSRs)
China NMPA Clinical Evaluation Reports
Our Clinical Evaluation Report Writing Process
We follow a rigorous process to ensure the highest quality reports:
- Initial Consultation and Device Assessment
- Literature Review and Clinical Data Collection
- Report Drafting by Expert CER Writers
- Quality Assurance and Regulatory Compliance Check
Clinical Evaluation Report Samples and Templates
Need inspiration? Check out our:
- CER Examples for Various Device Classes
- EU MDR CER Templates
- Sample Clinical Evaluation Reports (Redacted)
These resources can help you understand what a well-crafted CER looks like.
Our Team of CER Writers and Consultants
Our stellar team includes:
- Experienced Clinical Evaluation Report Writers
- Regulatory Affairs Specialists
- Clinical Research Experts
- Medical Device Professionals
With our diverse expertise, we ensure your CERs are both scientifically sound and regulatorily compliant.
Additional Clinical Report Services
Beyond CERs, we also offer:
- Clinical Study Report (CSR) Writing
- Post-Market Clinical Follow-Up (PMCF) Reports
- Clinical Investigation Reports
- Clinical Performance Reports for IVDRs
Training and Resources
Want to build your in-house capabilities? We offer:
- Clinical Evaluation Report Writing Training
- CER SOP Development
- MDR Clinical Evaluation Report Guidance
- Webinars on CER Best Practices
Why Regular CER Updates Are Crucial
Keeping your CERs up-to-date is critical for:
- Maintaining EU MDR Compliance
- Addressing Post-Market Surveillance Data
- Incorporating New Clinical Evidence
- Ensuring Continued Market Access
Don’t risk your device’s regulatory status – stay current with regular updates!
Get Started with Our CER Writing Services
Ready to elevate your Clinical Evaluation Reports? Here’s how to get started:
- Free Initial Consultation
- Custom Quote Based on Your Device and Needs
- Secure and Confidential Process
- Satisfaction Guaranteed
Frequently Asked Questions
A Clinical Evaluation Report (CER) is a comprehensive document that demonstrates the safety and performance of a medical device based on clinical data and evidence.
Under EU MDR, CERs should be updated at least annually for high-risk devices and every 2-5 years for lower-risk devices.
As often as your patient’s condition changes – which in some cases, might be as frequently as you change your scrubs!
A CER evaluates all available clinical data for a device, while a Clinical Study Report (CSR) documents the results of a specific clinical trial.
CERs should be written by qualified professionals with expertise in the medical device field, clinical research, and regulatory requirements.