We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Topics » Medical Devices » Quality

Quality
Quality RSS Feed RSS

GPC Medical Lands Warning Over Process Validation, Labeling Problems

December 28, 2017
The firm said it would make corrections but failed to include a plan or documentation.  Read More
RedWarningStamp.gif

Nurse Assist Distributed Unsterilized IV Saline Syringes, FDA Says

December 28, 2017
The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More

Patient Engagement Continues to Grow, Despite Difficulties

December 15, 2017
The shift to increased patient input for device development and clinical trials in recent years has been more challenging than expected, according to participants at the FDA/CMS Summit. Read More

Patient Engagement Continues to Grow, Despite Difficulties

December 13, 2017
The percentage of FDA-approved clinical trials that include patient-reported health outcomes has reached 80 percent, CDRH Director Jeff Shuren said at the FDA/CMS Summit. Read More

FDA Warns ProSun Over Failure to Correct Tanning Bed Exposure Time

November 20, 2017
The company’s correction failed to resolve the issue. Read More

FDA Proposes Framework for Quality Manufacturing Pilot Program

November 13, 2017
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

October 9, 2017
Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new technologies. Read More
Brazil map

Brazil Revamps GMP Inspections to Improve Access to New Technologies

October 5, 2017
The agency plans to consider the manufacturing stage of the device. Read More

DHS Flags Hacking Risk in Philips’ Radiation Monitoring App

September 12, 2017
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

Chinese Medical Equipment Barred From Import by FDA

September 12, 2017
The FDA cut off imports from a Chinese manufacturer of hospital beds, stretchers and operating-room tables after an inspection discovered multiple violations of quality standards, the agency said in a warning letter. Read More

DHS Flags Hacking Risk in Philips’ Radiation Monitoring App

September 1, 2017
The Department of Homeland Security issued an advisory over major software vulnerabilities in two versions of Philips Healthcare’s web application DoseWise Portal that can give hackers access to protected electronic patient health information. Read More

DHS Flags Hacking Risk in Philips’ Radiation Monitoring App

August 29, 2017
The software is used in the U.S., Australia, Japan and Europe for simplifying the analysis of collected radiation exposure doses. Read More
Previous 1 2 3 4 5 6 7 8 9 … 23 24 Next

Upcoming Events

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 27Jul

    Applying the Lessons of the Pandemic to Your Upcoming Trial

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Warns Baby Neck Floats Used in Water Therapy Can Cause Death or Injury

  • U.S. Government Inks $3.2 Billion Contract With Pfizer-BioNTech for Vaccine Booster Campaign

  • FX Receives FDA Clearance for Its FX V135 Shoulder Arthroplasty Platform

  • FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing