• Streamline Quality Management
  • GxP Compliance
  • QMS & Med. Compliance
  • GxP Training
  • Resources
  • Why eLeaP
  • Blog
  • Learning Management (LMS)
  1. Blog
  2. ISO 14971

Currently browsing "ISO 14971"

  • QMS

    16 articles

  • 21 CFR Part 11

    7 articles

  • Pharmaceutical Manufacturing

    7 articles

  • QMS

    6 articles

  • Aviation Industry

    6 articles

  • Quality Management System Software

    6 articles

  • Medical Devices

    5 articles

  • Compliance Culture

    5 articles

  • Quality Management Systems

    5 articles

  • Change Control

    4 articles

  • Laboratory Quality Control

    4 articles

  • FDA Inspections

    4 articles

  • Quality

    3 articles

  • ISO

    3 articles

  • cGMP Guidelines

    3 articles

  • Clinical Evaluation

    3 articles

  • CAPA

    3 articles

  • ISO 13485

    2 articles

  • ISO 14971

    2 articles

  • Supply Chain

    2 articles

  • Aviation Compliance

    2 articles

  • Audit Management

    2 articles

  • Quality Control

    2 articles

  • ICH E6 R3

    2 articles

  • Design Controls

    2 articles

  • FDA

    2 articles

  • Uncategorized

    2 articles

  • NCR Report

    2 articles

  • Medical Equipment

    1 articles

  • FMEA Template

    1 articles

  • ISO 14971

    Understanding ISO 14971: Comprehensive Guide to Risk Management for Medical Devices

    eLeaP Editorial Team

    November 13, 2024

    18 min read

    Understanding ISO 14971: Comprehensive Guide to Risk Management for Medical Devices

    Abstract ISO 14971 is one of the most widely accepted standards that offer a coherent process for managing medical device risks. This paper aims to evaluate the incidence of risks, regulatory provisions, and risks to patients concerning the entire lifecycle of a device. It also includes an extensive examination of procedures for assessing and controlling […]

    Continue reading

  • Medical Devices

    How to Implement Medical Device Risk Management

    eLeaP Editorial Team

    September 3, 2024

    9 min read

    How to Implement Medical Device Risk Management

    Risk management ensures medical devices’ safety, efficacy, and regulatory compliance. Effective risk management helps mitigate potential hazards that could impact patients, healthcare providers, and manufacturers in an industry with high stakes and a stringent regulatory landscape. The critical role of risk management in medical device development cannot be overstated. It involves identifying, evaluating, and controlling […]

    Continue reading

About eLeaP

  • About eLeaP®
  • Excellence
  • Learning Management
  • Performance Management
  • Quality Management

Capabilities

  • Quality Management System
  • Learning Management System
  • Performance Management System
  • 21 CFR Part 11 LMS
  • 14 CFR Parts 145, 135, 43, 91, 121 LMS
  • Free Downloadable SOPS
  • Brochures

Articles

  • Quality Management
  • Quality Management Software
  • QMS

Support

  • Resources
  • Glossary
  • Sitemap

Get in Touch

(877) 624-7226

support@eleapsoftware.com

  • Contact eLeaP
  • LinkedIn
  • YouTube
  • X
  • Facebook

© 2002 - 2025 Telania, LLC.