STD Med, Inc. Receives Second Brazil GP Approval And Adds Med-Tech Regulatory Consulting Service
STOUGHTON, Mass., May 3, 2013 /PRNewswire/ -- STD Med, Inc. is pleased to announce that it has received a second Certificate of Good Practices for Manufacturing of Class III Medical Devices from ANVISA, the Brazilian National Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria –ANVISA). All medical devices must be registered with ANVISA before being sold in Brazil. The Certificate of Good Practices was granted to STD Med after an intensive audit by the Brazilian agency. The audit process is a comprehensive inspection of policies, procedures and facilities and can often take a number of years to complete. It is one of the primary hurdles for new medical device product registration in Brazil.
SyncMedical LLC, a subsidiary of STD Med, Inc., worked in partnership with Sinnergy Medical, one of its Brazilian distributors, to achieve approval in less than four months. "SyncMedical is uniquely positioned to further assist in establishing emerging new technologies in Brazil," said Steven Tallarida, President of both STD Med, Inc. and SyncMedical LLC, "with a distribution network of 13 offices in Brazil, SyncMedical has the ability to establish medical device sales and marketing support for any U.S. based company looking to launch their products into Brazil and Latin America."
STD Med, Inc. has also added both U.S. and International Contract Regulatory Consulting Services to their suite of offerings. The regulatory consulting service team will be managed by Christine Santagate, a seasoned engineering and quality professional with over 12 years of quality and regulatory (QR) experience. "I look forward to assisting STD Med customers by creating custom strategies to achieve regulatory compliance in this highly standardized industry" stated Ms. Santagate. STD Med is being proactive in offering outsourced quality and regulatory processes as the industry shifts to more cost effective and capital efficient management of internal operations. Significant cost savings and man-hour reductions can be achieved by engaging a contract regulatory consultant and STD Med, Inc. looks to provide a best in class quality and regulatory service offering.
About STD Med, Inc.
STD Med, Inc. is a rapidly growing and emerging leader in the development and manufacture of medical devices and precision machined components. Established in 1953, STD Med, Inc. is a privately held company with 3 facilities in Massachusetts which are ISO 13485:2003, ISO 9001:2008, JPAL and FDA approved. Over the past several years STD Med, Inc. has incubated and invested in several new technologies including Angiolink Corporation (acquired by Medtronic), Arthrosurface Inc., Spirus Medical, Inc.(acquired by Olympus), Cardiosolutions, Inc. and Saphena Medical and it is our intention to continue to pursue disruptive innovation in the medical device marketplace. Contact: Ron Murphy 508-942-8477 [email protected]
SOURCE STD Med, Inc.
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