April 2022
MD&M West
Visit us April 12-14, 2022 in booth #2896! Don't miss our tech talk, "Particulate and Medical Devices: Past, Present, and Future", taking place Tuesday, April 12th at 12:30pm in the Tech Theatre.
Find out more »AN INTRODUCTION TO THE U.S. FDA’S INVESTIGATIONAL DEVICE EXEMPTION (IDE): A GCMI WEBINAR
Ted Heise, PhD, RAC, Vice President of Regulatory and Clinical Services, will be a panelist on this upcoming webinar. What will attendees learn? What’s required by FDA to get into an IDE trial: Hint: robust design history files, and answers to questions that validate or confirm clinical hypotheses. What clinical trials need to answer in order for the greatest potential for regulatory approval. Hint: key players include regulatory associates, internal review boards, contract research associates and design history file team…
Find out more »June 2022
October 2022
Biocompatibility Matters 2022
Limulus Bio is proud to present Biocompatibility Matters 2022, a two-day conference in Copenhagen created to bring you networking opportunities, speakers that guarantee scientific height and valuable industry insights regarding changes in requirement and case studies. Conference Day 1 October 5th, 9am - 5pm Understanding the device: Chemical Characterization (ISO 10993-18) Ted Heise, PhD, RAC, Vice President of Clinical and Regulatory at MED Institute, will speak about the current considerations for establishing a practical AET – incl. solvent exchange, concentration,…
Find out more »April 2023
Extractables and Leachables Summit 2023
This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. We will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, FDA guidances & other international regulatory requirements for best practices in materials and chemistry characterization for drugs, biologics, delivery systems, and primary & secondary packaging.…
Find out more »June 2023
OMTEC 2023
Booth #804
Find out more »February 2024
MDM West 2024
Visit us in booth #1678
Find out more »September 2024
MEDevice Boston 2024
Visit us in booth #946! Tech talk: Top 10 Regulatory Rules for Successful Submissions When: September 26th at 11:30am Where: Tech Theatre
Find out more »October 2024
TCT Conference
TCT Medtech Innovation Forum | FDA Programs for Your Medical Device Innovations: An Update Sunday, October 27, 9:30 AM — 11:00 AM EDT Room: FDA Theater, Innovation & Exhibit Hall (Halls A-C), Lower Level, Walter E. Washington Convention Center Neal Fearnot, PhD, will participate with other industry experts on this topic.
Find out more »November 2024
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