The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization

This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices, also provides a framework for manufacturers and suppliers to meet common regulatory requirements, and serves as a strong foundation to meet FDA Part 820 requirements.

Eyal Lerner
Eyal Lerner
90 Minutes
Product Id:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
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Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).

The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

The systems share many similar features but they are not identical. Could we have on the same site a QMS that complies with both requirements? Must we have one QMS that's complies with both, or we could have two QMS coexist on the same site? To answer it we should discuss the background of both documents, their legal status, what is expected by the regulatory authorities and some basic concepts in quality and medical devices quality in specific.

We should understand what is required by both, what is just semantically named differently and what is principally different between both documents. For instance, ISO requires quality manual (QM) while such term does not mentioned in the FDA QSR but policies and standard operating procedures, this can be settled relatively easy. Other issues requires more attention. We will point out the main features and what should be done from an aspect of a site or a manufacturer which wants to comply with both QMS.

Why should you Attend: For people in the medical devices industry which either develops or planning to market medical devices to USA and Europe and plan to implant a QMS that complies with both regulatory authorities and ask themselves how to do it correct and efficiently.

Areas Covered in the Session:

  • Introduction
  • Brief review of regulations and standard: status and history
  • ISO 13485:2016 short review
    • Principals
    • Quality management system
    • Management responsibility
    • Resource management
    • Product realization
    • Measurement, analysis and improvement
  • FDA QSR (21CFR820) short review
    • Quality System Requirements
    • Design Controls
    • Document Controls
    • Purchasing Controls
    • Identification and Traceability
    • Production and Process Controls
    • Acceptance activities
    • Nonconforming Product
    • Corrective and Preventive Action
    • Labeling and Packaging Control
    • Handling, Storage, Distribution, and Installation
    • Records
    • Servicing
    • Statistical Techniques
  • Comparison between both QMS
    • Common features
    • Variances between both
  • Terms/ vocabulary
    • Comparison between terms
  • Summary

Who Will Benefit:
  • Medical Devices Quality Personal (QA and QC)
  • Laboratory Managers
  • R&D Researchers of Medical Devices and Combined Products
  • Quality Control Staff
  • Regulatory Affairs (RA) Staff

Speaker Profile
Eyal Lerner is owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues: Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection (internal audits), compliance gap analysis, 3rd party audits (FDF and API's), Management Review, GMP, GLP,MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation. Eyal worked for the Israel National Accreditation Authority (ISRAC) as head of accreditation of chemistry and Biology and later on as audits director in Teva pharmaceuticals global quality unit. Eyal preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.

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