New York Professional Events List

Implementing ISO 13485:2016

Apr 27, 2017 - 09:00 AM - Apr 28, 06:00 PM
Courtyard by Marriott Raleigh-Durham Airport/Morrisville 2001 Hospitality Ct, Morrisville, NC 27560,

NC ,
ZIP: 27560
Phone: 1 929 900 1853

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.

This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns.

Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue with the Notified Body system. However, the EU intends to replace the directives with new regulations resulting in new versions of EN ISO 13485:2016 and EN ISO 14971:2012.

The workshop covers implications in particular regulatory systems including MDASP and its nonconformity grading system.

Why should you attend:

The transition to ISO 13485:2016 can be complicated and, for some companies, the period is short, depending on when the current certificate expires. Start planning and implementing as soon as possible. This workshop provides the knowledge and understanding to update your QMS.

Workshop Objectives:

Participants will learn the major changes in the new version of the standard. In addition, they will understand where the new standard and QSR do not agree. The primary objective is to give participants the understanding needed for an efficient and effective QMS update.

Who Will Benefit:

  • Quality managers
  • Management Representatives
  • Quality engineers
  • Quality assurance and quality control
  • Regulatory affairs managers
  • Regulatory affairs professionals
  • R&D managers
  • R&D engineers
  • Product design and development
  • Operations managers
  • Production managers and supervisors
  • Manufacturing engineers
  • Risk managers
  • Complaint system team members
  • CAPA team members
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
- For event ticket, contact +1 929 900 1853
Event Manager Contact: marilyn.b.turner(at)
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
This Event Listing is Promoted  by
New York Media Technologies LLC in association
with GlobalCompliancePanel.


Day 1 Schedule

Lecture 1:
Overview of ISO 13485:2016
Summary of the differences between ISO 13485:2003 and ISO 13485:2016
High level comparison with FDA QSR

Lecture 2:
Regulatory Framework
Transition period for certificates
EN ISO 13485:2016 and the MDD
The new QMS audit findings/nonconformance grading system
Implications of the EU's Medical Device Regulations

Lecture 3:
Management Responsibility
Quality Policy and Objectives
Responsibility and Authority
Internal Quality Audits
Management Review

Lecture 4:
Resource Management
Competence and Training
Work Environment and Contamination Control

Lecture 5:
Design and Development
Design Planning
Design Inputs and Design Outputs
Design Verification and Design Validation
Design Review
Design Transfer
Design Changes
Design Files
Day 2 Schedule

Lecture 1:
Supplier Management
Purchasing Information
Written Quality Agreements
Purchased Product Verification

Lecture 2:
Production Processes
Production Control
Installation and Servicing
Identification and Traceability
Control of Nonconforming Product

Lecture 3:
Process Validation
When to Validate
Validation Requirements
Software Validation

Lecture 4:
Monitoring and Measuring
Control of Equipment
Processes and Products
Data Analysis
Complaint Handling

Lecture 5:
Corrective and Preventive Action
Corrective Action
Preventive Action


Speaker Details

Dan O'Leary

President, Ombu Enterprises

Dan O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Event Categories
Keywords: fun, design , development , Fun , implement, learn, Management , professional, program , purchas


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