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Summer 2009
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MedTech IGNITE
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Mack
Molding, MassMEDIC Member, Receives ISO 13485 Certification and Launches
MackMedical
FOR IMMEDIATE RELEASE Mack Launches MackMedical ARLINGTON, Vt. (July13, 2009) – Mack Molding Co. is today announcing the formation of its medical products group, which the company is branding MackMedical. “We have been aggressively developing the medical manufacturing sector of our business for the past nine years by refining quality and supply management systems, hiring specialized staff, and adding new technology,” says Jeff Somple, president of Mack Molding’s Northern Division. “As a result, the medical market now represents a full 30 percent of our business, including several Class III medical devices, surgical equipment, and disposables for the orthopedic market. After this significant investment of time and resources, we now have all the markers in place to legitimately call ourselves MackMedical.” Located at Mack’s headquarters in Arlington, Vt., MackMedical is a focused group of staff --product development, program management, quality, regulatory, document control, purchasing, sales and production -- that is skilled in medical manufacturing. They manage all medical accounts, from upfront engineering through final manufacturing and distribution. “This is an engineering-intensive team with a medical manufacturing culture that understands the industry,” explains Kevin Bradley, business unit director. “The customer doesn’t have to spend time bringing us up to speed on the stringent requirements of this market.” More than a molder “We have developed a robust medical products group within Mack Molding that represents a rapidly growing segment of our overall business,” adds Somple. “Medical manufacturing will grow to 50 percent of our business in the near future, as we anticipate adding large-part clean room molding and other medical design services. -more-
The company’s headquarters plant has been ISO 13485 certified for medical device production for several years. Just this month, its prototyping division (Mack Prototype, Inc., Gardner, Mass.) earned ISO 13485 certification as well. Mack is a privately owned business that operates six facilities throughout the eastern United States. For more news and information about its applications and services, go to www.mack.com.
FOR IMMEDIATE RELEASE Mack Prototype Earns Quality Gold Standard for Medical Manufacturing GARDNER, Mass. (June 29, 2009) – The quality management system of Mack Prototype, Inc., a division of Mack Molding Co., has been independently audited and certified to be in compliance with the requirements of the ISO 13485 international quality standard for medical device manufacturing. The International Organization for Standardization (ISO), a prestigious network of national standards institutes from over 150 countries, created the standard to provide medical devices that consistently meet applicable customer and regulatory requirements. NSF International Strategic Registrations (NSF-ISR), an accredited registrar, carried out the third-party assessment and certification. “Achieving this quality hallmark uniquely positions us as a prototype house and low-volume manufacturer,” says President Ric Perry, “as many manufacturers our size are not certified to this stringent medical standard. It will put us at the table with major medical OEMs, who require suppliers to be certified to ISO 13485 in order to quote new projects. It will assure customers we are continually driving toward quality system improvement. And based on customer needs, it will allow us to partner with Mack Molding, which is FDA registered and has been certified to ISO 13485 for several years, to provide a low-volume solution for major medical OEMs.” Mack Prototype is a low-volume manufacturing company that specializes in SLA rapid prototyping, CNC machining, LIM polyurethane, and injection molding. The Gardner location houses eight injection presses (10-230 ton) for low volume, small-to-medium part molding. Mack Prototype complements Mack’s growing list of vertically integrated services, which includes product design and development, custom injection molding, sheet metal fabrication, printed circuit board assembly, and full product assembly and order fulfillment. -more- Mack Prototype Earns Quality Gold Standard for Medical Manufacturing 2
About NSF International Strategic Registrations (NSF-ISR) # # # # #
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