Regulatory Roadmap/ Technical Documentation Gap Analysis

IPN performs gap analysis, in order to assist the success of medical device development projects, with the ultimate goal of making the devices available in the intended markets. This analysis identifies data gaps in projects, procedures, and product portfolios, considering the regulatory requirements. The regulatory/market assessment gap analysis consists, among others, of the following steps: map out current policies and procedures; outline the regulatory and normative framework and determine which requirements the organization and/or project needs to meet; identify and analyze the gaps; establish concrete recommendations on how to resolve the gaps.