Medical Product Risks

FDA’s Role in Managing Medication Risks | FDA

https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/fdas-role-managing-medication-risks

FDA Facts: The Risks of Promoting Unapproved Uses

https://www.fda.gov/about-fda/innovation-fda/fda-facts-risks-promoting-unapproved-uses

The premarket review and approval provisions of the Federal, Drug, and Cosmetic Act (FD&C Act) are designed to help prevent harm to patients from unsafe and ineffective …

11 Critical Risks Facing the Healthcare Industry - Risk

https://riskandinsurance.com/11-critical-risks-facing-the-healthcare-industry/

Substandard and falsified medical products - World …

https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products

Substandard and falsified medical products and the Internet. Unregulated websites, social media platforms, and smartphone applications can also be direct conduits of substandard and falsified …

Medical Product Development Risks • Cortex Design

https://cortex-design.com/blog/medical-product-development-risks/

Cortex Content January 15, 2023 • 0 min read. Medical product development risks exist because medical device development is a complex process. It requires a thorough …

Establishing Overall Risk for Medical Devices

https://www.mddionline.com/news/establishing-overall-risk-medical-devices

For medical device makers, identifying and reducing their individual product risks is no longer enough. Clause 7 of ISO/IEC 14971 (published in December of 2000) …

Risk Management of medical devices under MDR

https://omcmedical.com/risk-management-of-medical-devices-under-mdr/

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR …

6 Critical Risks Facing the Pharmaceutical Industry

https://riskandinsurance.com/6-critical-risks-facing-pharmaceuticals/

1) Increased Competition from Generic Drugs. In 2017, the FDA began a push to get lower-cost generic drugs out to market faster. Once a new brand name drug is approved, it’s granted a 180-day period …

6 Common Risks of New Product Development – And How to

https://www.tapecon.com/blog/6-common-risks-of-new-product-development-and-how-to-mitigate-them

Risks during new product development. Technology risks – When incorporating new technology in a product, there’s a chance your team may have blind spots or lack …

Medical Product and Device Defects - FindLaw

https://www.findlaw.com/injury/product-liability/medical-product-and-device-defects.html

After the product passes to healthcare professionals, they still have a duty to inform patients of the warnings, side effects, and other risks associated with the product. …