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
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • 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

Robotic Surgical System Recalled Due to Malfunctions With Unintended Movement

November 17, 2023
An uncontrolled arm that rotated after operation stopped caused Asensus Surgical’s recall of its Senhance surgical system, which has been identified by the FDA as a class I recall, the most serious type of recall, because use of these devices may cause serious injuries or death. Read More

Timelines Reduced by 50 Percent Under Revamped CAPA Process, FDA Says

November 15, 2023
Companies often didn’t initial improvement actions under the original CAPA, FDA official says. Read More

Revamped CAPA Process Has Reduced Timelines by 50 Percent, FDA Says

November 13, 2023
After 19 pilot programs conducted with medical device companies, regulators and patient communities, CDRH’s revised CAPA process is showing a 60 percent closure rate in under 60 days and a 50 percent overall reduction in improvement timelines, say FDA officials. Read More

CAPA Verification of Effectiveness: Understanding Key VoE Principles

October 24, 2023
While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Read More

Potential Leak Onto Control Board Gets Hamilton Ventilator Recall Deemed Class I

October 23, 2023
The recall is considered a correction because the ventilator should be serviced, the FDA said, and then can be returned to use. Read More

Hamilton Ventilator Recall Deemed Class I for Potential Leak Onto Control Board

October 19, 2023
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall, as a potential leak could cause the machine to stop delivering air, which could lead to serious injury or death. Read More

Lessons From Experts in A Two-Part Series on CAPA Verification of Effectiveness

October 19, 2023
Part one of a two-part series on CAPA verification of effectiveness best practices. Read More

CAPA Verification of Effectiveness: Lessons From Experts in A Two-Part Series

October 17, 2023
A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process. Read More

Expert Insights on Process Validation for Devicemakers

April 28, 2023
The FDA requires devicemakers to verify that a product meets each of its design specifications, which is generally accomplished through postproduction inspection or testing. Read More

Why You Need a Quality Agreement With Suppliers

August 17, 2022
Although a quality agreement is not specifically required or defined in FDA regulations, the FDA may ask during an inspection to review any documents that describe the way you manage contract service providers. Read More

Hazard Analysis Key in Risk Management for Combo Products

September 14, 2020
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More

Hazard Analysis Key in Risk Management for Combo Products

September 11, 2020
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More
Previous 1 2 3 4 5 6 7 8 9 … 24 25 Next

Upcoming Events

  • 05Dec

    Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

  • 07Dec

    Proactive Supplier Management Using Quality Agreements

  • 13Dec

    FDA Inspection Overhaul: How Things Have Changed in 2023

  • 14Apr

    MAGI 2024: The Clinical Research Conference

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

  • Biden Offers Drug Supply Chain Fixes, but Think Tank Says Government Isn’t Doing Enough

  • FDA Gives Green Light to Medtronic’s Symplicity Renal Denervation System

  • T-cell Malignancy From CAR-T Cell Immunotherapies Gets FDA Investigation

  • Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue

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