Newsletter | February 22, 2024

02.22.24 -- Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices And Biopharma

FEATURED EDITORIAL

Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices And Biopharma

By Hemadri Doma, Tolmar Inc.

In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.

INDUSTRY INSIGHTS

Getting Biologic Products To The Market Faster With Containment Solutions

White Paper | By Abigail Hisler and Olga Laskina, West Pharmaceutical Services, Inc.

Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time-to-market.

Stainless-Steel Needles: Quantifying Cobalt Risk For EU Regulation

Case Study | By Dr. Laura Berardi, Stevanato Group

Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

Navigating The Complexities Of Micromolding For Medical Devices

Article | By Paul Runyan, Accumold

Discover how leaders in micromolding for medical devices are pushing boundaries to create innovative solutions that enhance patient care and quality of life.

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