BoneZone Journal: Risk Management Under ISO and MDR
March 10, 2020
How to Approach Risk Management Under ISO and MDR Updates by Virginia Anastassova, StarFish Medical Regulatory Affairs Manager/Senior QA Specialist, is the ASK THE...
April 20, 2021
The April 20, 2021 online edition of Medtech Intelligence (MTI) features FDA Introduces the Safer Technologies Program for Medical Devices by Tara Lysechko, Starfish Medical Senior QA/RA Specialist.
Sub headed “The program highlights the agency’s commitment to improving safety and supporting innovation, and is a welcome counterpart to the Breakthrough Devices Program,” the article describes eligibility criteria and features of the program.
“The Safer Technologies Program (STeP)was motivated by the FDA’s Medical Device Safety Action Plan, specifically to help drive the marketplace to develop safer technologies by providing regulatory incentives and scientific expertise. Like the Breakthrough Devices Program, STeP aims to expedite the development, assessment and review of eligible devices.”
“STeP is predicated on the FDA’s belief that there is an important public health benefit in advancing medical devices that offer a significant safety advantage in treating and diagnosing less serious diseases or conditions. Patients may experience fewer serious adverse events and the overall clinical benefit of a medical device may be improved.
This program highlights the agency’s commitment to improving safety and spurring innovation, and is a welcome counterpart to the Breakthrough Devices Program.”
Tara Lysechko is a senior QA/RA specialist at Starfish Medical. Lysechko has 11 years of natural health product industry experience in Regulatory Affairs, including seven years consulting to start-up companies. At StarFish Medical, Lysechko provides quality assurance and regulatory support for the design, development and manufacture of innovative medical devices. Previous experience includes working for biotechnology companies developing novel medicines. Lysechko holds a Ph.D. in Immunology from the University of Alberta.