Quality

ARTICLES

How to Avoid Common CAPA Pitfalls

FDA inspection reports consistently show that the corrective and preventive action process is the biggest inspection problem for medical device facilities. And those who have to implement CAPAs have plenty of questions about how best to manage them. Read More

FDA Proposes Framework for Quality Manufacturing Pilot Program

The FDA proposed a framework for a voluntary pilot program aimed at using industry assessments of manufacturing quality to reduce the agency’s oversight actions. Read More

Brazil Revamps GMP Inspections to Improve Access to New Technologies

Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster… Read More

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