Navigation Links
STD Med, Inc. Receives Second Brazil GP Approval And Adds Med-Tech Regulatory Consulting Service
Date:5/3/2013

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 rmurphy@stdmed.com


'/>"/>
SOURCE STD Med, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. NeuroSigma Receives Health Canada Approval for Its Monarch eTNS System for the Treatment of Drug-Resistant Epilepsy and Major Depressive Disorder
2. Scioderms SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa
3. Avanir Pharmaceuticals Receives Positive CHMP Opinion for Approval of NUEDEXTA in Europe
4. drchrono Receives Investment from Box
5. InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
6. iBio, Inc. receives Notice from NYSE MKT Staff that Company currently is not in compliance with an additional Continued Listing Standard
7. Idaho Primary Care Association Receives Cambia Health Foundation grant for "Idaho Patient-Centered Medical Home" development in Idaho Community Health Centers
8. ARMGO Pharma Receives $1 Million Award from MDA to Support Advancement of Rycal Compound ARM210 as a Novel Treatment for Duchenne Muscular Dystrophy
9. Prostate Cancer Patient Receives First Treatment Using Latest Version of Vitesse Real-Time Brachytherapy Planning System from Varian Medical Systems
10. Sophono Alpha 2 Hearing System Receives FDA Clearance for Use With MRI
11. Rotech Receives Approval of First Day Motions; Approvals Ensure Operations Continue Normally
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... , April 24, 2017 SW Safety ... protection, and comfort, announces the release of the latest ... This most recent example of leading edge nitrile glove ... pattern for 200% more tactile grip on wet and ... and durability. With TracTek and a suite of other ...
(Date:4/20/2017)... 2017  Vivify Health, the pioneer and market leader ... a very significant patent for the advancement of healthcare ... via digital health.  This landmark patent provides the company ... secures Vivify,s position as the leader in remote care.  ... first company to apply consumer mobile devices, wireless biometrics, ...
(Date:4/20/2017)... 20, 2017 Research and Markets has announced ... Driven by Rapidly Expanding Injectables Market and Increasing Usage of Complex ... ... technologies will rise from USD 20 Billion in 2015 to around ... Delivery Technologies - Innovation Driven by Rapidly Expanding Injectables Market and ...
Breaking Medicine Technology:
(Date:4/25/2017)... ... 25, 2017 , ... Splashtop Inc. , the worldwide ... new addition to the Mirroring360 product family combines device screen mirroring with screen ... enables educators, business professionals and individuals to stream or mirror app screens, music, ...
(Date:4/25/2017)... , ... April 25, 2017 , ... ... attempts to compare student test score performance for the 2015-16 school year across ... state’s voucher programs. Though it highlights important patterns in student test score performance, ...
(Date:4/25/2017)... (PRWEB) , ... April 25, 2017 , ... ... the way in unveiling cutting-edge birth defects research related to Zika virus during ... the world’s premier society for this important science. , The Teratology ...
(Date:4/25/2017)... ... ... Emergency Physician and Distinguished Professor of Emergency Medicine Bentley Bobrow will be featured ... publish in summer 2017. , Dr. Bobrow, MD, FACEP, FAHA, is an Emergency ... He also serves as Medical Director for the Bureau of Emergency Medical Services and ...
(Date:4/24/2017)... ... 2017 , ... LG CNS Healthcare Solutions debuted the next ... Telehealth 2.0, the American Telemedicine Association’s national conference. , BYOD has been added ... pre-programmed tablet in a remarkably easy-to-use kit for patients. “BYOD is the next ...
Breaking Medicine News(10 mins):