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MDI Announces ISO 13485 Certification

LANCASTER, Pa., Feb. 22, 2013 /PRNewswire/ --  Lancaster manufacturing pioneer, Mary Burton , and her son Ed Burton are picking up where they left off.  After a three year absence from the industry, the Burtons have reopened their doors for business with a new pristine facility dedicated to the production of orthopedic and spinal implants. Today, Mary and Ed are announcing the ISO 13485 Certification of their new venture, MDI, LLC.   

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"ISO Certification validates everything we've put into place over the past several months," says Ed Burton .  "It puts us in the position to once again become a superior, quality supplier in the marketplace."

"We are so excited to be back," says Mary Burton . "We felt we owed it to our customers and to our employees to rebuild the tremendous relationships we had in the past."

MDI (Medical Device and Implants) opened in July of 2012 to the delight of previous customers.  "MDI has exceeded our expectations for delivery and quality.  We have been extremely impressed with their talented team which began manufacturing for us quickly and efficiently.  We are looking forward to establishing a long term relationship that will produce great success for both companies," said Mahmoud Abdelgany , CEO, Custom Spine, Inc.

To re-launch their business, MDI recruited local highly-skilled craftsmen, engineers and inspectors, all of whom had worked for the Burtons in the past, some for well over 30 years.   "It was a no-brainer", says Greg Myers , VP Manufacturing and General Manager, when asked to join the team again.  "It's like having the family back together again.  This is an exceptional group.  We all work very well together."

"From the moment we opened, ISO 13485 Certification was the most important goal we had," says Terry Corl , Director of Quality.  After months of building a new Quality System from scratch, the streamlined, easy-to-use system proved to be a perfect starting point for MDI's ISO certification.  "We couldn't have been more pleased with the outcome of our four-day audit," says Corl.  "We received no minor or major corrective actions, nor did we receive any recommendations for improvement.  We are very proud!" 

With ISO certification under their belts, MDI is poised and ready to impress customers again, both old and new.  "Customers will benefit from our new high-tech equipment and our broad range of manufacturing, inspection and finishing capabilities," says Ed Burton

Mary Burton opened her first screw-machine facility in 1962 as The HDJ Company, serving the Industrial Market.  In 1992, she formed SMD (Specialized Medical Devices) which focused specifically on the Medical Device Industry.  In 2004 Mary was honored as one of MD&DI's 100 Notable People in the Medical Device Industry.  Mary was also a 2008 recipient of PMPA's Gold Micrometer Award for 46 years of service and a Lifetime Achievement Award. She is now serving as Vice President of Sales & Marketing for MDI and Ed Burton is leading the new company as President.

For more information contact:  Jill Tenny at or 1-717-945-7451 ext.202         

SOURCE Medical Device and Implants, LLC
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