Custom injection molder PTA Plastics (Longmont, CO) announced that it is one of the first companies in the country to receive MedAccred Plastics Injection Molding accreditation, following a pilot with MedAccred in Plastics Mechanical Assembly.
As reported in PlasticsToday in June 2016, MedAccred (Warrendale, PA) is a medtech-industry-managed program that provides supply chain oversight via standardized audit criteria. It is administered by Performance Review Institute, a not-for-profit organization that also supports the Nadcap accreditation program for the aerospace industry. Modeled after this successful 25-year-old program, MedAccred audits replace some of the routine critical process supplier audits conducted by many OEMs and contract manufacturers with a single audit.
PTA Plastics received the accreditation on Aug. 8, 2019, by demonstrating its ongoing commitment to quality by satisfying customer requirements and industry specifications. The company is now part of the MedAccred Qualified Manufacturers List (QML), proving increased supply chain visibility as PTA Plastics continues to offer manufacturing solutions in the medical field.
"The accreditation benefits PTA because we now understand and have adopted many plastics assembly best practices that ultimately improve our quality and our ability to satisfy our customers," Greg Fish, Quality Assurance Manager, told PlasticsToday. Customers can rest assured that “the processes used at PTA have been reviewed by industry experts and meet their expectations and requirements,” added Fish.
PTA is certified to ISO 13485, the international quality management standard specific to the medical device industry, but MedAccred brings additional value because it is narrower in scope, according to Fish. “The process differs from ISO 13485 significantly. Typically, the scope of an ISO audit is very broad, having to cover numerous clauses, whereas MedAccred focuses entirely on the process itself,” said Fish. You could characterize an ISO audit as being a mile wide but only an inch deep, while the “MedAccred audit is an inch wide—covering just the process—but a mile deep. MedAccred brings PTA confidence that our processes are consistent, thorough and effective,” said Fish.
MedAccred was created to counter manufacturing-related issues experienced by medical device OEMs. Subscribers and active participants in the program represent a veritable who’s who of the medical device industry, from Baxter and Johnson & Johnson to Medtronic. The process to become MedAccred certified is vigorous, because of the focused scope, creating the need for a comprehensive review to ensure that industry best practices are met, removing the need for multiple OEMs to make on-site audits, explained PTA. Its certification is valid through October 2020.
The medtech industry accounts for approximately three-quarters of PTA’s business. The company offers a comprehensive range of design and development, mold making, injection molding, over molding and value-added services.
PTA uses state-of-the-art CNC and EDM technologies with fully equipped mold shops at its locations in Colorado and Connecticut, and builds approximately 200 molds per year. The company owns 32 molding presses ranging in size from 30 to 1,375 tons, most of which are equipped with robots that can be operated around the clock.