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Read MoreEnsuring Full Compliance with the EU In Vitro Diagnostic Regulation
The European Union’s In Vitro Diagnostic Regulation (IVDR) has brought significant changes to the regulatory framework for diagnostic devices. It introduces stricter classification criteria, requires more comprehensive clinical evidence, and enhances oversight by Notified Bodies. As a result, manufacturers face notable challenges in obtaining and maintaining CE marking.
Precision Clinical Services offers comprehensive IVDR consulting to ensure a smooth transition from IVDD to IVDR compliance or to help launch new IVD devices under the updated regulation. Our consultants are experienced with Class A to Class D IVDs, companion diagnostics (CDx), and software as medical devices (SaMD), ensuring regulatory clarity and faster approvals.
IVDR Consulting
Why Choose Us
Our team has extensive experience in the medical device industry, ensuring that every report is accurate, detailed, and meets the highest standards of quality.
We stay up-to-date with the latest regulatory requirements, including ISO 14155 and FDA guidelines, to ensure your reports are fully compliant and ready for regulatory review.
From study design to data analysis and interpretation, we provide thorough documentation that supports the safety and efficacy of your medical devices.
We understand that each clinical investigation is unique. Our services are tailored to meet your specific needs, providing you with personalized support throughout the entire process.
We know the importance of timely submissions. Our efficient processes and dedicated team ensure that your clinical investigation reports are delivered on schedule.
Our Services Include:
•Protocol Development
•Data Collection and Management
•Statistical Analysis
•Report Writing and Review
•Regulatory Submission Support
Why Choose Precision Clinical Services for IVDR Consulting?
EU IVDR Expertise
Deep understanding of evolving EU regulatory expectations
Cross-Functional Team
Regulatory consultants, clinical writers, and quality experts
Notified Body Experience
Familiarity with TÜV SÜD, BSI, DEKRA, and others
Custom-Tailored Guidance
Strategies for both high-risk (Class C & D) and low-risk devices
End-to-End Support
From early planning to post-market surveillance and beyond
Our IVDR Consulting Services Include:
Gap Analysis & Regulatory Strategy Development
IVDD vs. IVDR compliance gap assessments
Performance Evaluation & Clinical Evidence
Performance Evaluation Plan (PEP) and Report (PER) preparation
Technical Documentation Authoring & Review
Compilation of IVDR-compliant Technical Documentation
Notified Body and Submission Support
Notified Body identification and communication support
Post-Market Surveillance (PMS) & Vigilance
Field safety corrective actions (FSCA) and vigilance strategy