Ensuring that Medical Devices and IVDs deliver the performance, safety, and medical benefits they claim is a complex task. Therefore, it is crucial to understand the assessment processes involved and how to implement them effectively. At Veranex, we strategically evaluate your clinical approach, aiming to increasing the coherence and the dependability of all aspects considered, while maintaining an innovative and business-oriented lens throughout our assessment.
A sound clinical strategy enables your team to collect relevant clinical evidence to meet requirements, identify risks, plan appropriate mitigation measures, and pinpoint areas for product improvement.
The team at Veranex possess the knowledge and experience necessary to develop a robust clinical strategy that supports your product’s distinct claims.
Clinical Evaluation for Medical Devices
Especially in Europe, Medical Device manufacturers must prepare a Clinical Evaluation file that meets all relevant EU Regulation requirements. This entails a rigorous analysis of the state of the art, leading to defining safety and performance claims, and medical benefit.
Demonstrating these claims requires thorough analysis of scientific literature, product development and testing information, and readily available clinical evidence. Veranex’s specialists will support you through this challenging process by defining and executing a clinical development plan grounded in statistical, scientific, and clinical justification.
Performance Evaluation for IVDs
Devices used for diagnostic purposes on human specimens must meet the General Safety and Performance Requirements (GSPRs) required by Regulation (EU) 2017/746 (IVDR). Compliance with these requirements involves a continuous performance evaluation process that adheres to a well-defined, methodologically-sound approach, based on a device-specific plan, i.e., the Performance Evaluation Plan (PEP).
Veranex’s IVDR experts collaborate with you to design and implement a customized strategy, tailored to your specific challenges and requirements, including PEP/PER updates, clinical performance study design and execution, and defining adequate PMS and PMPF plans and reports.
How does it feel to work with the Veranex Clinical Strategy Team?
Our top priority is creating a robust clinical strategy that aligns with your product and commercial goals.
Working closely with your team, we establish the intended use, indications for use, safety and performance claims, and medical benefit. We explore different options and provide detailed information on how each option impacts the overall clinical development plan, enabling you to make well-informed decisions.
We routinely conduct a systematic review and analysis of the scientific evidence, available clinical data and technical documentation, with a focus on risk management, verification/validation and usability.
Based on our findings, we establisha clear clinical development plan that may involve pre and/or post market clinical investigations. Our Clinical Investigation team then ensures this plan is efficiently executed in a cost-conscious manner.
We integrate the results in a clinical evaluation report that supports market approval. Furthermore, we continue supporting you with post-market activities to further substantiate or expand your claims, assess residual risks, and ensure ongoing compliance.
Clinical Strategy Services & Capabilities:
- Clinical Strategy
- Development of clinical strategies and evidence planning requirements from first-in-human through pivotal studies
- Performance of study design development (first-in-human, early feasibility, feasibility, pivotal, post-market, etc.)
- Identification of relevant clinical endpoints pertinent to safety AND/OR performance of the device
- Definition of clinical study type (e.g. superiority, non-inferiority, equivalence)
- Performance of comprehensive literature searches
- Sample size considerations
- Statistical Analysis Plan (SAP) definition
- Compilation of the Clinical Investigation Plan (CIP) in compliance with the Good Clinical Practice principals defined in ISO 14155
- Development of clinical study documentation (clinical protocols, Informed Consent, investigator and site agreements, clinical management and safety plans, etc.)
- Assembly of Investigator’s Brochure
- Identification and selection of Clinical Study Sites
- Structure of eCRF architecture
- Compilation of other relevant components of the Trial Master File (TMF)
- Interactions with Regulatory Authorities (Notified Bodies, National Competent Authorities, Ethical Committees)
- Submission of Clinical Trial Application (CTA)
- Registration of a clinical study in national registries
- Management of amendments
- Preparation of clinical sections of regulatory submissions
- Clinical and Performance Evaluation
- Definition of intended use, indications and claims (performance, safety, medical benefit)
- Preliminary clinical strategy
- Writing of clinical evaluation plan/performance evaluation plan, clinical development plan and clinical evaluation report/performance evaluation report, all according to applicable regulations and guidelines:
- MEDDEV 2.7/1 Rev.4
- MDR 2017/745
- IVDR 2017/746
- MDCG 2020-1
- MDCG 2020-13
- MDCG 2022-2
- Summary of Safety and Clinical Performance (MDCG 2019-9)
- Post-Market Surveillance (PMS/PMCF)