FDA Announces Release of “Playbook for Threat Modeling Medical Devices”

NAMSA Expands Minneapolis Preclinical Laboratory to Meet Industry Demand for Medtech Research and Development Solutions

NAMSA, the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today the expansion of its Minneapolis preclinical research laboratory. This expansion will add 55,000 sq. ft. to the current 130,000 sq. ft. preclinical campus in Minneapolis.

FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions

In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop a draft revised version of “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (2005), the agency, on November 3, 2021, has issued draft guidance—“Content of Premarket Submissions for Device Software Functions.”   

Interventional Oncology: Fast Forward to the Future

As cancer has surpassed cardiovascular diseases and is now the leading cause of death worldwide, its conquest remains elusive despite recent notable progress. Cancer remains an incredibly complex disease, involving virtually every tissue in the body and affecting many genes.

MDCG Publishes New Legacy Device Guidance 2021-25

Following the release of the Medical Device Coordination Group (MDCG) guidance 2021-24 on 4 October, 2021, MDCG published additional guidance, MDCG 2021-25 Regulation (EU) 2017/745, dated 21 October, 2021.