At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.
The PQRI Parenteral and Ophthalmic Drug Product Leachables and Extractables (PODP L&E) Working Group has posted a brief update on their work to develop a risked–based approach for evaluation and safety qualification of leachables in PODPs, and Dr. Mary Richardson, iuvo’s Chief Scientific Officer, is a member of the PQRI Working Group. The update is […]
When developing a new pharmaceutical product, it is important to assemble the right team with the right expertise to enable an effective development program with the highest probability of success. For startup companies who are focused on one or two assets, it frequently is not possible to hire all the individual specialties required to develop […]
Drs. Mary Richardson and Kathleen Krenzer co-authored a guest blog for Hall Analytical Laboratories on biocompatibility in the characterization of medical devices. The blog post can be found here.
December 21, 2020 – For the fourth year in a row, the iuvo BioScience Community Outreach Team adopted a family in need to help provide for the Christmas holiday. The family provided a wish list, and iuvo was able to give gifts to them, including several boxes of food and gift cards. Delivery was made […]
September 18, 2020 – iuvo BioScience is one of two local companies partnering with Rochester Regional Health to assist with the increasing demand for coronavirus testing. There has been a shortage of Transport Media, so iuvo teamed up with the healthcare provider to produce this essential part of the test kit. “The local ecosystem that […]
September 8, 2020 – The FDA issued a guidance document on September 4, 2020, on Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process”. This document is available on the FDA’s website here. This guidance document, which supersedes the 2016 version of […]
March 8, 2020 – iuvo’s Dr. Mary Richardson and Dr. Kathleen Krenzer, members of iuvo’s Lumino Advisors Consulting Group, guest-taught a class on biocompatibility to a group of biomedical engineers on Friday, March 6. The class was a graduate level class taught by Dr. Greg Gdowski at the University of Rochester’s Department of Biomedical Engineering, […]
January 19, 2020 – The updated version of ISO 10993-18, the standard covering the chemical characterization of the ISO 10993 biocompatibility standard for medical devices, has just published. The new version is available here. The ISO 10993 series applies to devices where the material or medical device has direct or indirect body contact, with ISO 10993-1 […]
December 18, 2019 – In the spirit of giving back to those a little less financially fortunate, the iuvo BioScience Community Outreach Team adopted two families in need to help make their holidays a little bit better. This is the third year in a row that iuvo has participated in the program. The parents provided […]
November 21, 2019 – iuvo BioScience Chief Scientific Officer Dr. Mary Richardson will be speaking on career paths at the University of Rochester on Monday, December 2nd, at 4:30pm ET. Mary is a graduate of the University of Rochester (Toxicology, 1994) and will be speaking along with one other UR alum on career paths outside […]
