Quality

ARTICLES

DHS Flags Hacking Risk in Philips’ Radiation Monitoring App

The Department of Homeland Security issued an advisory over major software vulnerabilities in two versions of Philips Healthcare’s web application DoseWise Portal (DWP) that can give hackers access to protected electronic patient health information. Read More

How to Manage Risk in a World of Changing Design Control Standards

How does the changing landscape of international standards overlap with design control, and how should devicemakers account for these changes in their risk management plans? Read More

Device Industry Should Strive for Quality and Compliance in Parallel, Experts Say

Simply being FDA compliant — even if you’re following every regulation as closely as it can be followed — may not be enough to make your medical device one of high quality, and it is high quality devices that will not result in recalls or adverse events. Read More

483 Roundup: FDA Cites Firms Over Complaint Handling, Other Deficiencies

The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints. Read More

Device Firms Issue Advisories Following Ransomware Attack

Siemens Healthcare and Becton Dickinson issued advisories following the WannaCry ransomware attack. Read More

FDA Warns Lonza Over Production, Validation, Cleaning Procedures

The FDA warned device manufacturer Lonza over inadequate validation, CAPA procedures, and other violations at its Walkersville, Md., facility. Read More

Risk Rankings Can Help Manage Suppliers, Expert Says

Combining various risk metrics into a single number can help manufacturers rank suppliers according to risk and … Read More

FDA Adds Device Scenarios to Final GMP Guidance for Combo Products

The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More

New ISO Standard Updates Luer Connector Design

The International Organization for Standardization has released a standard that specifies design and performance requirements of small-bore Luer connectors used in intravascular applications or hypodermic connections in medical devices and accessories. Read More

New ISO 13485 Expands on QSR Supplier Requirements

What has always been implicit in the FDA’s Quality System Regulation is spelled out in detail in the 2016 version of international standard ISO 13485. Read More