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 News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Topics » Devices » Quality

Quality
Quality RSS Feed RSS

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

FDA Launches Device Software Pre-certification Pilot

August 4, 2017
The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of the new approach is to determine whether a company meets the necessary quality standard. Read More

FDA Warns Ohio Devicemaker Over Validations, Complaint Procedures

July 19, 2017
Investigators found the facility’s complaint procedures did not include evaluating complaints to determine if an investigation was needed. Read More
[SPONSORED CONTENT]

What Device Manufacturers Can Learn From FDA’s Inspection Data

July 19, 2017
Companies in China, Germany and the United Kingdom should take heed, as they are the companies most often getting OAIs. Read More

What Device Manufacturers Can Learn From FDA’s Inspection Data

July 17, 2017
Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
FDA_Logo_Blue_2016.gif

What Device Manufacturers Can Learn From FDA’s Inspection Data

July 14, 2017
Companies in China, Germany and the United Kingdom should take heed, as they are the companies most often getting OAIs. Read More

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

July 10, 2017
The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints. Read More

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

July 10, 2017
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

MHRA Updates Guidance on UK Notified Bodies

July 7, 2017
In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK. Read More

India Changes Acceptance Criteria for IVD Test Kits

June 30, 2017
India’s Ministry of Health and Family Welfare has revised the acceptance criteria for in vitro diagnostic devices to detect HIV, HBsAg and HCV. Read More

Four Devicemakers Cited for Inadequate Procedures

June 30, 2017
The FDA cited Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques over problems with their CAPA procedures, complaint handling and MDRs. Read More
Previous 1 2 3 4 5 6 7 8 9 … 23 24 Next

Upcoming Events

  • 28Sep

    The Cost of Counterfeiting: Why You Need a Plan to Secure Your Medical Device Supply Chain

  • 28Sep

    Calculating Sample Size to Satisfy FDA Expectations

  • 11Oct

    GMP Quality Management vSummit 2023: Where Quality Meets Risk

  • 16Oct

    MAGI@home Clinical Research Conference 2023

  • 26Oct

    FDA in 2024: What to Expect in an Election Year

  • 08Nov

    18th Annual FDA Inspections vSummit

Featured Products

  • FDA, FTC and DOJ Enforcement of Medical Device Regulations

    FDA, FTC and DOJ Enforcement of Medical Device Regulations

  • Using Real-World Evidence in Drug and Device Submissions

    Using Real-World Evidence in Drug and Device Submissions

Featured Stories

  • Manufacturing Cost is Key Issue Facing Gene Therapy Products, Marks Says

  • Artificial Womb Technology Not Yet Ready for Human Trials Adcomm Says

  • Top Concern for CBER is Marketing of Unapproved Biologics, Says FDA Official

  • FDA Deems Medline Industries’ Saline Solution Vial Recall as Class 1

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 or Share My Data
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing