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API – Using ISO:13485 for Medical Device Management
With the help of: TMAC
About
The Challenge
TMAC has helped us identify the areas and methods of improvement while assisting us implement our medical device management system. We look forward to the potential growth this can bring our organization in the coming years and look forward to continuing our longstanding relationship with TMAC.
MEP's Role
The implementation project phase lasted for nine months and entailed adding the ISO:13485 requirements to the existing quality management system infrastructure - document and records control, training and competence. There was special emphasis placed on the statutory and regulatory requirements of the ISO:13485 medical standard, as there was little experience within the organization working with FDA and COFEPRIS (Mexican counterpart agency to FDA) requirements. TMAC assisted API in finding the applicable requirements of their product, along with the reporting and labeling requirements that are the key to regulatory compliance.
The medical device management system was implemented and completed and is pending Phase II certification in the fall of 2022. The potential medical customers have accepted the Phase I audit results and have begun issuing purchase orders for converted sub-components, in addition to the medical device files for manufactured components that are to be produced. This has opened up a new market to API, which has allowed them to begin scouting new business opportunities in both the United States and Mexico.