After a very long and cold wait, Spring is finally here! This is also the time of the year when our team at EMMA International is busy and consumed with our annual Spring conferences and annual meetings. The team and I were in D.C. this past week for both the Food and Drug Law Institute’s (FDLI) annual conference, as well as the Medical Device Manufacturers Association’s annual meeting. Once again, both organizations did an outstanding job with the events. It was great to catch up with colleagues, see familiar faces, and make great connections.
At FDLI’s conference, our Compliance Practice Lead, Brian Dahl, represented EMMA International on a panel discussion with Dr. Jeff Shuren, Director, Center for Devices and Radiological Health. The panel discussed the latest policy developments, enforcement actions, and priority initiatives for 2018. Also at FDLI, there was a lot of chatter about our new Cybersecurity services, given the recent focus of the agency.
At MDMA’s annual meeting, Dr. Gottlieb’s chat with Mark Leahy (President/CEO of MDMA) was very interesting. The conversation focused on FDA’s strategy for 2018 and beyond, and the top initiatives that Dr. Gottlieb is focusing on. I must admit the MDMA annual meeting is one of my favorite events to attend. You walk out with very valuable information, great connections, and opportunities for collaborations.
With the industry preparing for the new EU MDR, the transition to ISO 13485:2016, Cybersecurity concerns, the EMMA International team is ready to take on any of these challenges. We know that preparing for the new EU MDR is a cumbersome task; however, by engaging our services, you can rest assured that you are relying on true subject matter experts. Similarly, the transition to ISO 13485:2016 has proven to be a daunting task to many manufacturers. Our ISO 13485 SMEs are here to help you maneuver the intricacies of the new requirements and accomplish the transition in an expeditious manner. Mark Treacy (EMMA International’s Cybersecurity Practice Lead) and his team are also here to help you understand this ever-changing space and do the necessary due diligence and needs assessment to ensure that you are protected.
In closing, I would like to leave you with a final nugget of information concerning our EQMS solution (QualiPro). It is the ONLY intelligent EQMS in the global market place. More than 900 companies, and 100,000 users in Asia, Africa, and the EU rely on QualiPro to meet their needs. I encourage you to reach out to Patrick Powell (EMMA International’s Director of EQMS) to schedule a demo so you can see this platform in action.
As always, I encourage you to reach out to me personally should you have any questions.
Carmine Jabri, PhD, MSQM, MHA, MSJ