ABA-PGT Inc., a fully integrated producer of precision tooling and high-volume, tight-tolerance plastic gears and other technical molded parts, recently received its ISO 13485:2003 Medical Device Certificate.
While ABA-PGT is not solely dedicated to the medical device industry, Terry R. Holmes, VP sales and marketing, said the medical device certification adds another level of credibility and value to the company’s capabilities.
“The majority of our business is to produce the tooling and provide the molding technology for plastic gears, which is our core area of expertise,” said Holmes in a telephone interview. “For several years, however, we’ve been doing non-gear precision parts in the medical device market that often lend themselves to the expertise we’ve developed in small, precision gear parts. That’s how we entered into the medical device field—through our high level of precision.”
ABA-PGT, headquartered in Manchester, CT, is a diverse custom molder that, in addition to gears and medical, provides components for the automotive, water management, HVAC, and business machine/paper path market segments. Currently the company operates with 52 molding presses ranging in size from 17-110 tons, and employs approximately 100. Holmes said that the company is looking to expand its tonnage range going forward.
Obtaining its ISO 13485:2003 Medical Device Certification gives the company a competitive edge when approaching companies in the medical device industry, Holmes explained. “I think the greatest benefit to having the medical certification is so that additional medical device companies will feel more comfortable working with us,” Holmes stated.
In addition to the ISO 13485:2003, ABA-PGT has its ISO 9001:2008 certification and is also in the process of becoming certified to the TS automotive standard as well. “Certification ensures ABA-PGT’s continued adherence to customer specifications and regulatory requirements,” added Holmes. —Clare Goldsberry