A Clinical Evaluation is a mandatory regulatory requirement under EU MDR (2017/745) and IVDR (2017/746), ensuring that every medical device demonstrates proven safety, performance, and clinical benefit.
At Qualitech International, we provide fully compliant, evidence-based Clinical Evaluation Reports (CER) developed according to MDCG guidance and Notified Body expectations.
Our team ensures that your clinical evidence is complete, accurate, and ready for review—reducing delays, minimizing non-conformities, and strengthening your product’s market acceptance.
Our Clinical Evaluation Services
We provide end-to-end support covering all aspects of Clinical Evaluation, including:
- Comprehensive Clinical Evaluation Reports (CER)
- Systematic Literature Review (SLR)
- State-of-the-Art (SOTA) assessment
- Clinical evidence mapping & gap analysis
- Benefit-risk evaluation
- PMS & PMCF integration
- CER updates and MDR transition support
Why Choose Qualitech International ?
We bring deep knowledge in MDR/IVDR clinical requirements to ensure fully compliant evaluations.
Our reports are structured, validated, and built on strong scientific and clinical data.
We support manufacturers with Class I to Class III and high-risk IVD devices.
Our methodologies follow industry-approved standards trusted by CA & NB reviewers.
We deliver clear timelines, continuous communication, and smooth project execution.
Whether you are a manufacturer, CA reviewer, or NB assessor, we adapt our approach to your needs.
Frequently Asked Questions
Have questions about regulatory compliance, market access, or our services?
Here are answers to the most common inquiries from Medical Device and IVD manufacturers.
Comprehensive Gap Analysis
Before submission, we conduct a rigorous, simulated Notified Body audit of your existing Technical File. We identify compliance gaps against current MDR/IVDR standards and provide a strategic, actionable roadmap for remediation.
Technical File Creation & Remediation
Whether you are building from scratch or transitioning legacy devices to the new regulation, our specialists write and compile robust Technical Files, ensuring complete traceability between risk management, clinical evaluation, and design control.
Clinical Evaluation Reports (CER) & PERs
Documentation doesn’t end at certification. We design structured PMS plans, PMCF/PMPF strategies, and Periodic Safety Update Reports (PSUR) to keep your devices continuously compliant on the market.
Post-Market Surveillance (PMS) Plans
Documentation doesn’t end at certification. We design structured PMS plans, PMCF/PMPF strategies, and Periodic Safety Update Reports (PSUR) to keep your devices continuously compliant on the market.
