Submission Management
Core Compliance provides submission management services to ensure regulatory compliance. Understanding the stringent application procedures, formats, and regulatory requirements and directives from global regulatory agencies can be overwhelming, our regulatory consultants can manage the CE Marking process.
CE Mark Submission Management
Our regulatory consultants provide CE Mark submission management guidance. Medical devices or products you must first satisfy the requirements for CE Marking, to nations within the European Union (EU) and the European Free Trade Association a conformity mark that signifies a product has met all criteria of the relevant EU directives, especially in the areas of Safety and Performance.
1- Confirm medical device status and class- Determine what classification
2-Identify and meet essential requirements- required to be deemed acceptable in terms of certain key areas:
3-Technical Documentation- In compliance with the criteria
4-Perform Conformity Assessment- The classification of the medical device determines which assessment route a manufacturer may take for CE mark.
Submission Management
Core Compliance has extensive experience is in consulting companies throughout each aspect of FDA requirements for Medical Device companies for FDA 510k submission management. A 510(k) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.
Step 1: Pre 510(k) submission gap analysis and requirements evaluation- we will assist you to design of your device help us determine the proper FDA product code and regulation number
Step 2:FDA 510(k) submission completion- When all documentation is completed we will prepare your final 510(k) submission
Regulatory Road Map
Regulatory road map for compliance requirements. Medical devices can sometimes feel like a moving target. The regulatory function in the healthcare industry is critical in order to make safe and effective products available worldwide. Regulatory guidance documentation and testing requirements as well as risk assessments.
Core Compliance guides companies in the development of a clear plan for FDA Section 510(k) clearances, the Premarket Approval (PMA) and Biologics License Applications (BLA) processes that aligns with and your internal processes and procedures.
We will help you pinpoint the information you need to develop a regulatory strategy, and then hit the ground running. Learn the next steps you need to take to bring your device to market.
ISO Standards
