Medical device clinical evaluation involves collecting, analysing, and interpreting clinical data to assess the initial and ongoing safety, effectiveness and performance of the device. This is an ongoing process conducted throughout the device’s life cycle.
Clinical evidence (data) is required for all classifications of medical devices, software and IVDs as part of the regulatory process. In Australia and the EU, clinical evidence is mandated to comply with the Essential Principles and General Safety and Performance Requirements (GSPR).
The manufacturer is responsible for defining the scope and type of clinical evidence required based on device classification, intended purpose and risk profile.
DevDx is adept at evaluating and integrating your clinical evidence requirements into your global regulatory and commerical plans. We will ensure that the clinical evidence is collected, analysed and documented in the most time-efficient and cost-effective means and that it will satisfy the requirements of your preferred regulatory and commercial jurisdictions.
Our expertise spans medical devices, SaMD, IVDs and diagnostics from proof of concept/scientific validity, pilot, analytical validation, pivotal and clinical performance studies. We are experts in the implementation of clinical evaluation and clinical performance studies according to ISO 14155 and ISO 20916, respectively.
Our services:
- Development of an integrated clinical evidence, regulatory and commercial strategy
- Development of Clinical Investigation Plans or Study Protocols
- IRB/HREC submissions
- Clinical study documents, e.g. Participant Information Sheet/Consent Form, Case Report Forms
- IVD sample collections for proof-of-concept and analytical validation studies
- Guidance on in-house IVD (LDT) development
- Clinical Evaluation Reports (CER)
- Post-market clinical follow up (PMCF)
