ERI Group

Jamie Haggard we are so proud to be supporting Green Sun Medical's mission! This is an amazing product!!!

Having an amazing time reconnecting with old friends and meeting new ones at MedTech Innovator Summit - refilling my motivational cup by the minute hanging out with brilliant people tackling the toughest problems in healthcare. Thanks Ranjini Srikantiah and Jessica Richter for a fabulous session yesterday preparing the mentors for this year’s innovator cohort, and Paul Grand and team for another great event. #medtech #innovators #erigroup

Having an amazing time reconnecting with old friends and meeting new ones at MedTech Innovator Summit - refilling my motivational cup by the minute hanging out with brilliant people tackling the toughest problems in healthcare. Thanks Ranjini Srikantiah and Jessica Richter for a fabulous session yesterday preparing the mentors for this year’s innovator cohort, and Paul Grand and team for another great event. #medtech #innovators #erigroup

Are you a clinical laboratory already offering a Laboratory Developed Test (#LDT) and think you are still under enforcement discretion by FDA according to the FDA LDT Final Rule? You may want to think twice about that. The targeted enforcement discretion now applied to LDTs offered prior to the FDA Final Rule only apply if the test meets the strict definition of what FDA considers an LDT. Many LDT manufacturers/ laboratories have been marketing “LDTs” for years that do not fit the FDA’s definition. If this is the case , these tests must comply with the premarket and QMS requirements of FDA regulated IVD tests.  Unsure of your LDT path and future strategy? Let the experts at ERI guide you through the process and make sure you are compliant with this ever changing landscape. Connect with us: [email protected] or learn more: https://lnkd.in/eNa34kDd

  Meet Jon Wojculewicz! He is a Senior Consultant with the Regulatory Affairs team at ERI Group and has 20 years experience in medical device industry. He recently wrapped up a pre-submission application to the FDA for an at home test system that enables users to conduct lab-like hormone tests through a fingerstick blood sample. This new device may eliminate the need to visit a phlebotomist. Outside the office, Jon enjoys traveling and exploring and is a volunteer firefighter.

From all of us at ERI Group, happy Memorial Day weekend!

A big congrats to Mikki Larner and David Schnur Associates for this honor and for promoting STEM education and careers! #STEM #STEMeducation #STEMcareers #meddevices #medicaldevices

This week, the regulatory space for clinical laboratory tests known as LDTs (Laboratory Developed Tests) was forever changed with the release of FDA’s long awaited Final Rule which now asserts their authority to regulate these as In Vitro Diagnostic Devices (IVDs). What does this mean for your clinical diagnostic tests? Let ERI’s regulatory and compliance experts help you through this transition. We specialize in very pragmatic and action-focused planning and have 30 years expertise in lining up your FDA concerns with your business needs. Connect with us at [email protected] or learn more: https://lnkd.in/eysanFET

Headed to DeviceTalks this week! Next stop: Boston. We help bring medical products to market and would love to connect. Comment below or email Jose Ramirez [email protected] #medtech #meddevice https://lnkd.in/eJaNh-Cm

Team ERI celebrating our new Manufacturing site with the entire team. Exciting next chapter! #contractmanufacturing #medicaldevicemanufacturing #meddevicemanufacturing