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:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced ... attorneys chosen by their peers for this recognition are considered among the top 2 ... received special honors as members of this year’s Legal Elite Hall of Fame: ...
Breaking Medicine News(10 mins):