International Medical Devices Industry: FDA to Transition to ISO 13485

Table of Contents

Enquire Now

Got questions? Let's help you find the answers.
By clicking "Submit" you agree to have read the Privacy Policy and agree to the terms. You can unsubscribe at any time by clicking the link in the footer of our emails.

The U.S. Food and Drug Administration has announced that it will transition to ISO 13485:2016 after conducting a comparative analysis between the latter and the current Quality System Regulation (QSR).  

In an official update from the FDA in December 2018, the reasons for and benefits of implementing ISO 13485 as the benchmark for quality management system audit inspections are outlined. In the presentation, the agency states: “The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.

The FDA also recognizes that there will be implications not only for FDA itself, which will have to retrain its inspectors and other staff as well as adapt its audit inspection requirements, but also for medical device production companies in the U.S. – especially those which have not been certified against ISO 13485:2016 before.

The transition to ISO 13485:2016 from the FDA will come alongside the coming into force of the MDSAP (Medical Device Single Audit Program) as conceived from the IMDRF (International Medical Device Regulators Forum) and EU MDR 2017/45 (the Regulation of the European Parliament and of the Council). The transition is about to happen soon, but impacted organizations will be able to adjust as long as they conduct the necessary management system changes, gap analyses, and internal audits.

Crest Advisory Africa is here to help individuals to get trained and certified and organizations to get audited and certified against ISO 13485

Comments

3 Responses

  1. Hi
    Thanks for the great feedback.
    We appreciate it a lot.
    There are view horror stories about medical devices and the regulatory requirements regarding these.

    Please check out the article we have send out this morning. This is very interesting in terms of Personal Identifiable Information (PII). Here is the link: https://www.crestadvisoryafrica.com/iso-27701-2019-pims-international-certification-to-protect-personal-identifiable-information-pii/
    Please also look at the video which has a link in the article.

Leave a Reply

More Quality Articles

Strategic Risk Assessment: Navigating ISO/IEC 27001:2022 and ISO 31000:2018

Strategic risk assessment is a critical component of an organization’s risk management framework.

What is a Combined Assurance Matrix?

Unlock the power of effective risk management with a Combined Assurance Matrix (CAM)!

10 Reasons to Acquiring the ISOLTX GRC-A Software System

Discover how the ISOLTX GRC-A Software System can enhance operational efficiency, streamline compliance, and foster collaboration among your…

Unlocking Success: How Internal Audit Strengthens Risk Management for Strategic Goals

Internal Audit verifies and enhances Risk Management’s role in achieving strategic objectives.

Conducting Internal Context Analysis: A Guide to ISO/IEC 27001 and ISO 31000 Integration

Internal context analysis is crucial for effective risk management and information security in organizations.

Continuous Evolution: Implementing Continual Improvement in Your ISMS

Continual improvement is a fundamental principle of effective Information Security Management Systems (ISMS).

Driving Continuous Improvement: Implementing Management Review for Effective ISMS Performance

Management review is a critical process within the performance phase of an Information Security Management System (ISMS).

Ensuring Compliance and Continuous Improvement: Implementing Internal Audits in ISMS Performance

Internal audits are a critical component of the performance phase in the management of an Information Security Management System (ISMS).
Receive our latest news

Subscribe To Our Newsletter

Get notified about GRC-A training, advisory, auditing and software.