Medical device OEMs and suppliers of injection molding services to the medtech industry may learn a thing or two from a new course developed by the American Injection Molding (AIM) Institute (Erie, PA).
AIM has announced that John Anes, an independent consultant with more than 30 years’ management experience in medical device development, manufacture and quality systems, will lead a course on quality systems for medical injection molding in August at the AIM headquarters in Erie.
The three-day course was developed for both OEMs and molding companies that are involved in the manufacturing of medical devices, said AIM. The course will cover regulatory requirements, referencing FDA (21 CFR) and ISO 13485 standards. Included in the course will be information on the steps involved to achieve ISO certification.
The course material covers a review of documentation requirements for part and mold design, instruction on mold/process validation and document control requirements for injection molding.
An emphasis on critical areas of the quality management system will include a review of the Device Master Record, product acceptance, calibration, employee training, material traceability and product non-conformance. Completion of the course gives companies detailed methods to compete at a higher level by implementing process systems that will improve product quality and company performance, according to AIM.