ACE Medical Company™ follows regulatory guidance from both the Food and Drug Administration (FDA) and the International Standards Organization (ISO) 13485 Quality Management System. We do this through several approaches all of which assure our customers delivery of quality products. Each approved supplier is given a risk class based on critical suppliers, non-critical / higher risk and low risk manufacturers. Determination is given based on risk class of the product, and amount of annual business conducted. All suppliers are monitored either annually or semi-annually through evaluation, either of business records, or in person audits at any of our manufacturing facilities around the world. Communication with manufacturers, service providers and post market surveillance confirm are used to monitor and maintain the quality of our delivered finished product.
Approved FDA and ISO standards require manufacturers to have sufficient Corrective and Preventative Actions (CAPA) systems in place to respond to all customer complaints. All complaints received by ACE Medical Company™ are recorded and follow a step-by-step decision tree approach to determine appropriate CAPA’s. All complaints then are processed through a thorough Root Cause analysis to determine a solution and prevent similar events from happening again. Once cleared all reports and findings are shared with our valued customers and solutions are proposed.
If everyone is not fully committed to quality, the program will have limited success. At ACE Medical Company™, all of our valued employees and partners are committed to delivering exceptional solutions for complex issues, we are 100% dedicated to every aspect of our QMS. Continuous education, training and testing for employees (and contractors is essential). Training matrices are created for each position within our organization and everyone is works together and trains on new processes. New processes can add efficiencies, but constant monitoring and evaluations are necessary to validate and confirm quality is maintained. ACE Medical Company™ support and sales staff are all educated in OR protocol and training on products such as the meatal dilator, Isabella Forceps and Kelly Forceps.
Distribution records and traceability of products are essential requirements of both the FDA and MDR. Knowledge of product location and end destination, and the ability to locate affected lot numbers in any recall are requirements for medical device manufacturers. Agreements must be in place for distributors to be able to assist with end destination for products. It should be positively noted that neither ACE™ nor Wiggins Medical™ Companies have never had any product recalls in over 40 years of business. The ACE Medical Company™ also maintains records of all our in-house factory repairs that are traceable directly to each unique instrument. Everything is validated and recorded with our direct mark 2D data matrix lifetime tracking system.
As a final quality check and a commitment our customers of always achieving better we conduct regular post market surveillance for all of our products. This involves surveys with you, the customer to determine a variety of factors and help us better understand your unique situation. The feedback we receive is used to help design new products and processes that help them deliver exceptional patient care. This final check is ACE Medical Company’s quality system is validated and serving your patients best interests.