MtechGroup

FDA has been working on the design and development of the Global Unique Device Identification Database (GUDID). The UDI Final Rule was published on September 2013.

Identifying Medical Devices Will Strengthen Safety | FDA Voice Identifying Medical Devices Will Strengthen SafetyPosted on September 20, 2013 by FDA VoiceBy: Jeffrey Shuren, M.D., J.D. Medical devices are an important part of everyday life for many people. Some are used to diagnose, others to treat patients. Some are implanted in the body. Some are used by doct...

Frequently Asked Questions about the New Device Registration and Listing Requirements

(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm?source=govdelivery)

This list of FAQs is being provided to assist medical device establishments with understanding the new requirements and responsibilities for registration and listing that will become effective October 1, 2012.

Frequently Asked Questions about the New Device Registration and Listing Requirements

Mammography Quality Standard Act Update (9/10/2012):

MQSA National Statistics
In this section of the MQSA Scorecard, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.
Certified facilities, as of October 1, 2011 8,620
Certification statistics, as of September 1, 2012
Total certified facilities / Total accredited units 8,639 / 12,456
Certified facilities with FFDM2 units / Accredited FFDM units 7,447 / 10,887
FY 2012 inspection statistics, as of September 1, 2012
Facilities inspected 7,605
Total units at inspected facilities 10,612
Percent of inspections where the highest noncompliance was a:
Level 1 violation 0.8%
Level 2 violation 13.1%
Level 3 violation 2.5%
Percent of inspections with no violation 83.7%
Total annual mammography procedures reported, as of September 1, 20121 39,373,128
1 This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies. Facilities are asked to disclose this information at their initial accreditation, and then at the time of their re-accreditation, which takes place once every three years. FDA began collecting these data in 1998. The aggregate does not reflect the current number of procedures performed at these facilities, but only the numbers reported by them during the three-year period prior to the current date. We have aggregated only the numbers reported by certified, non-Veterans Administration facilities.
2 FFDM - Full Field Digital Mammography unit.

Look forward to UKC 2011 in August for the opportunity to network with the brightest minds in biomedical technology and engineering...

UKC 2011 | US-Korea Conference on Science, Technology and Entrepreneurship To celebrate the 40th anniversary of KSEA, together with KOFST, join us with your family and friends at Park City, Utah. It is just 30-minutes from Salt Lake City International Airport, a gateway to several national parks including Yellowstone National Park, the first national park in the USA. The C

Plan of Action for New FDA 510K Review Process:
http://mtech-inc.net/news_alerts

Mtech Group - News Alerts Welcome to News Alerts, your source for news articles and press releases related to the medical device regulatory affairs in the US and Canada.

Please visit Mtech Group website for informative resources regarding the latest medical device regulatory affairs.

http://mtech-inc.net

We assist the FDA in communications with the foreign establishment
responding to the questions concerning the foreign establishment's devices that are imported into the US.
We prepare all medical device approval documents, such as 510K application, and submit the documents to an appropriate regulatory agency such as FDA and HC on behalf of our clients.

What We Do
We provide a consulting service concerning the matters pertaining to the operation of medical device manufacturer establishment registration, device listing with the FDA, and medical device approval on behalf of our clients. We work as a US agent of our clients in any transactions or communications with the FDA and HC during the medical device application, review and approval process.

Mtech Group keeps up and stays current with the latest dental and medical device technologies to provide the most effective medical device regulatory related consultation to our clients who wish to enter the North American market!!!