Mind the Gap
The analysis will include classification, as well as a detailed data review of your preliminary or previously existing regulatory compliant product documentation, related processes, data and company practices. Relevant labeling issues, including future EUDAMED requirements, will be part of this step.
Furthermore, we analyze your internal quality management system (ISO 13485:2016), if already implemented, and check the product and economic actor registrations, as well as supplier and distributor arrangements.
A central aspect is the assessment of the clinical evaluation: medical evidence, product performance and the testimony of benefits, are key to put a safe product on the market. Finally, we will review your risk management and check your Post-market surveillance measurements and plans.
Based on these outcomes, a systematic and objective regulatory business strategy for the European market can be defined piece by piece. The implementation will then be prioritized based on defined milestones.
The gap analysis will thus be the basis for an efficient and feasible project and business strategy to close all gaps and reassess the compliance after all mandatory actions are implemented.
Moreover, a comprehensive gap analysis will allow for criteria like time, workload and costs to be scored. Thus, activities to achieve compliance, certification and audit readiness, on a rational basis, can be coordinated.
Kalms Regulatory team will guide you in a flexible and agile way to meet all the requirements with an optimized strategy. The focus will be a tailor-made and efficient way of compliance in the multidimensional regulation framework. This strategy will include a discrete timeline, define the overall workload and costs and will thus allow you to prioritize activities to reach compliance, certification and audit readiness.