Gap analysis of Technical Documentation for Medical Devices and IVDs
Ensure your medical device/IVD Technical Documentation complies with MDR and IVDR requirements through a targeted, modular, and strategic approach.
Why is a Gap Analysis a strategic move today?
The European regulatory framework for medical devices and in vitro diagnostic devices is constantly evolving. Recent amendments to the MDR and IVDR, updates to harmonized standards, and the gradual implementation of EUDAMED require manufacturers to regularly assess documentation compliance and proactively implement actions to ensure consistent device performance and safety throughout the product lifecycle.
In this context, Gap Analysis is a a strategic tool to:
- Anticipate Notified Body expectations
- Prevent non-conformities and delays in certification processes
- Plan targeted and sustainable interventions, even on specific sections of the technical documentation, such as clinical evaluation, risk analysis, or biological evaluation
A flexible and targeted service
The Gap Analysis can be performed on the full technical documentation or on selected components, including:
- Clinical evaluation / performance evaluation
- Risk management
- Post-market surveillance documentation (PMS/PMCF)
This modular approach enables focused interventions, optimizing time and resources.
Clariscience delivers Gap Analysis through a structured, action-oriented methodology based on standardized checklists, methodological review of key documents, and precise recommendations to address any gaps.
You will receive a clear report with defined intervention priorities, which we discuss together to facilitate corrective action planning.
Who is it for?
This service is designed for:
- Manufacturers of medical devices and IVDs undergoing regulatory transition
- Organizations aiming to prevent documentation-related non-conformities during certification
- Investors or buyers seeking to assess the compliance level of a product portfolio prior to acquisition
