A gap analysis is intended to examine and identify the differences between the current state of development of the Medical Device (MD) and In Vitro Diagnostics (IVD) and what the situation should be to ensure certification is obtained.
Conducting a Gap Analysis will help to improve your development process efficiency by allowing the identification of gaps, and then help to define the objectives and needs that will allow your product to transition to the required end goal (e.g. enter into clinical stage, fulfill the clinical evaluation, obtain the CE mark, etc.).
A Gap Analysis report delivers a detailed plan of the next steps and future milestones for the product to reach the foremost objective in the most efficient and successful way.
How can DDR help?
- DDR will analyze whether the available data from the MD or IVD is able to support the intended purpose in light of the new Medical Device Regulation (MDR) requirements and, if not, will suggest activities required to meet these requirements.
- DDR will analyze the possibility of claiming equivalence with another MD and what additional data is required in the event that the equivalence may not be guaranteed.
- DDR will identify issues in the current MD or IVD development and suggest the best approaches to adopt in order to obtain the CE mark. DDR will identify the requirements that should be addressed in the post-market activities of a MD.