NASHUA, N.H., July 27, 2011 /PRNewswire/ -- Mass Design Incorporated has been awarded ISO 13485:2003 certification by the International Standards Organization (ISO), enhancing this printed circuit board manufacturer's competitive position as a supplier to medical device manufacturers worldwide.
ISO 13485:2003 is an internationally recognized accreditation that establishes protocols to assure the safety, quality and performance of medical devices – including components such as the PCBs that are at the heart of devices ranging from pacemakers to MRI machines.
"Gaining this latest ISO Certification is an affirmation of the quality we have been delivering to the medical device industry for over a decade," said Paul Boduch, vice president and cofounder of the company. Since its founding 25 years ago, Mass Design (http://www.massdesign.com) has built its reputation for high-reliability circuit boards among customers that include Siemens, Nova Biomedical, GE Healthcare, Baxter and Tyco.
ISO 13485:2003 specifies a quality management system and record-keeping standards needed to meet customer and regulatory requirements applicable to the manufacture medical devices and components. The recent certification is in addition to the quality processes and standards Mass Design adopted under the broader and more widely recognized ISO 9001:2008 manufacturing standard.
"Our people are to be commended for developing the internal audit system, spot check mechanisms, and communication protocols needed to meet ISO 13485 standards. The new medical certification adds value to our printed circuit board products and the Mass Design brand and serves to increase customer confidence globally," added Boduch.
In addition to ISO 13485, Mass Design is further establishing its position in the medical manufacturing sector with the addition of new technology and sophisticated equipment. For example, the company just added a Schmoll Drilling Machine and an additional MyData Machine to its 75,000 engineering and production facility just north of Boston.
Moreover, Mass Design has been leading the way with flexible circuit board technology that allows medical device manufacturers to cram more functionality into smaller spaces while enhancing reliability. Flexible circuit boards integrate circuitry and wiring into a single unit that can conform to just about any shape. For example, Mass Design produces flexible circuit boards for prosthetic limb manufacturers.
"ISO 13485 will play a key role in our sales growth, which increased 18% this year in the medical electronics sector – diagnostic and monitoring equipment, surgical tools and both implantable and non-implantable medical devices," said Bill Gately, Mass Design's sales manager.
Mass Design fabricates printed circuit boards (PCBs) for original equipment manufacturers as well as manufacturing fully assembled printed circuit boards with all components installed.
The International Standards Organization (ISO) is the world's largest developer and publisher of international standards for manufacturers across nearly every industrial sector. Representatives are based in 162 countries while a Central Secretariat, based in Geneva, Switzerland, coordinates the ISO system.
SOURCE Mass Design Incorporated