Industry Update
MDSAP- Don’t Let the World See Your Dirty Laundry
Do you want the world to see your dirty laundry?  If not, then E.M.M.A. International can help you prepare for the new Medical Device Single Audit Program (MDSAP).  MDSAP full implementation is in effect as of January 1, 2017 .

The Medical Device Single Audit Program will soon be mandatory if you sell medical devices in the following markets: Canada, USA, Brazil, Japan or Australia. 

The MDSAP will be both a time and cost savings for companies. Medical device manufacturers will be able to have  one single quality system audit that would encompass the five markets below  vs. having to complete five separate audits. The MDSAP will cover all country specific requirements for:
  • Therapeutic Goods Administration of Australia
  • Brazil’s Agência Nacional de Vigilância Sanitária
  • Health Canada
  • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
  • US FDA

One single audit report will be shared among all the participating authorities. Each market will no longer hold their market audit report confidential. MDSAP reports will be accepted by FDA as a substitute for routine FDA inspections.

How does your QMS laundry list look? Think about how solid is your CAPA system, Complaint handling, purchasing controls. Is your internal audit schedule current and in compliance with your QMS?

Do you want the world to see your dirty laundry? If not, then have E.M.M.A. International perform pre-audit review of your quality system to prepare you for the official MDSAP audit.

Time is running out! The Pilot program is already over. Only MDSAP certificates will be accepted by Canadian regulators after 31 December 2018.  

In the News
E.M.M.A. International Consultant Honored

The Colorado Section of the American Chemical Society honored E.M.M.A. International consultant Helen Gerhard with the Salutes to Excellence Award.

Congratulations Helen!
Happy Valentines Day

Roses are red. Violets are blue. 

Call E.M.M.A. International and we will come and help you! 

OQA - The Right Solution for You!

As part of our ongoing efforts to integrate the OQA program into our offerings & services, we have recently partnered with a team of Engineering graduate students from the University of Michigan to put together a “go to” market strategy for marketing the OQA Program.

This is an exciting joint venture that has given us the opportunity to introduce our quality and regulatory services to the students. As a firm, we take on a “scholar practitioner” type of approach to the work that we do. Therefore, naturally, a partnership with an institution such as the University of Michigan was an excellent fit with our business model. We are looking forward to receiving their feedback and taking our OQA program to the next level.

If you are interested in learning more about our OQA program that allows companies to outsource all, or part, of their Quality Assurance activities for a flat monthly fee, contact us today!  

On the Road with E.M.M.A. International
On Social Media:  #ontheroadwithemmainternational
E.M.M.A. International CEO Speaks at a Right Place, Inc. Event
Carmine Jabri, President and CEO of E.M.M.A. International spoke at a January event sponsored by The Right Place, Inc. 

Dr. Jabri presented on the services offered by E.M.M.A. International. Additionally, Dr. Jabri took questions presented by the attendees regarding quality and regulatory challenges within their respective companies. 
2017 Events
17-18 MichBio- Conference & Expo
Kalamazoo, MI
24 The Right Place- Presenter
Grand Rapids, MI

14 MedHealth Summit
Tech Town, Detroit, MI
8-9 MDMA-FDA Forum
Palo Alto, CA
21 FMMC Executive Breakfast Series St. Petersburg, Florida  

26 MASCPA- Annual Event
York, PA
26-28 MDMA Annual Meeting
Washington, DC
4-5 FDLI- Annual Conference
Washington, DC
8-9 FMMC-Annual Symposium
St Petersburg, FL
13-15 MD&M East
New York, NY  
20 FMMC Executive Breakfast Series
St. Petersburg, Florida
21 FMMC Executive Breakfast Series
St. Petersburg, Florida
14 FMMC Executive Breakfast Series
St. Petersburg, Florida
TBD-FDLI Enforcement Conference
Washington, DC

*List is constantly updated.  Please check our website for a current list of events. Click here