Article | August 30, 2016

Analyzing and Understanding ISO 13485 Proposed Changes

Date: Tuesday, August 30, 2016
Time: 1:00pm-2:30pm, EDT US
Duration: 90 Minutes - Online
Price: $279 - Includes Bonus Handouts!

Course Description:

In the highly regulated medical device world, standards and regulations are continuously evolving to ensure that the highest levels of quality and safety are achieved. Through this course you will be able to assess your existing quality system processes and understand the changes that will need to be implemented in your organization to comply with the revised ISO 13485 Standard and to meet expectations from notified bodies.  Learn how you can prepare your quality and compliance teams to prepare for the new requirements while improving existing processes.

This 90-minute session will cover the latest updates and timelines around the 3rd revision of ISO 13485 and an update on the current status of MDSAP.

Discussion topics include:

  • Assessing the ISO 9001:2015 changes and its implications on the new ISO 13485:2016 standard.
  • Discussing the current status of ISO 13485:2016
  • Understanding the most critical changes proposed for the new Medical Standard.
  • Analyzing the impacts of the ISO 13485:2016 key additions to an existing quality system
  • Understanding the areas of increased emphasis and how Notified Bodies will assess the changes to the new standard.
  • Understanding the objective evidence that would need to be in place to satisfy the new ISO 13485 Requirements.
  • Discussing a strategy to conduct a robust gap assessment between the previous standard and the new changes.
  • Evaluating industry best practices to effectively implement ISO 13485:2016.
  • Highlighting the actions medical device manufacturers should be taking and pitfalls to avoid for a successful implementation of the new standard.

Who Will Benefit From This Course?

This course is ideal for:

  • Professionals from Quality, Compliance and Regulatory Affairs who have oversight of medical device regulated processes and products 
  • Auditors of medical device manufacturing firms (internal and external)
  • Cross functional team members implementing standards and regulations

Your Expert LSTI Instructor - Marcelo Trevino

Marcelo Trevino is an Experienced Senior Director with Nihon Kohden America, one of the fastest growing manufacturers of Patient Monitoring equipment in the U.S. with a large global footprint. Marcelo directs the Quality and Regulatory Affairs initiatives at the Corporate Headquarters in Irvine, CA.  The product lines include Enterprise Patient Monitoring as well as Neurology and Cardiology equipment.  Prior to Nihon Kohden America, Marcelo led Quality Systems and Regulatory Compliance initiatives for several years as a Senior Manager at Medtronic’s Heart Valve manufacturing Center of Excellence.

Mr. Trevino has an extensive knowledge of medical device management systems (ISO 13485:2003) and international medical device regulations for the United States (FDA QSR), Australia (Therapeutic Goods, Medical Devices Regulations), Canada (SOR/98-282 and Canadian Medical Devices Conformity Assessment System), Japan (Pharmaceutical Affairs Law), and Europe (93/42/EEC Medical Device Directives). He holds a B.S. degree in Industrial and Systems engineering from ITESM in Mexico and an MBA in Supply Chain Management from the W.P. Carey School of Business at Arizona State University. He is also a certified Quality Management Systems Lead Auditor by Exemplar Global and has consulted with several corporate executives in medical device firms to implement different process and quality improvement projects. Additionally, he is a Certified Six Sigma Black Belt and Biomedical Auditor through the American Society for Quality (ASQ) and holds Certificates in Environmental & Sustainability Management Regulatory Affairs Management from University of California, Irvine.

Recorded Course Details

This is the full 90 minute recording of the live training session conducted by Marcelo Trevino. You will receive all handouts included in the live training session and have unlimited access to the course for 30 days.

Why Choose A Life Science Training Institute Course?

  • At LSTI, we are committed to providing the highest quality instruction AND instructors.
  • LSTI instructors go through a rigorous selection process.  We hire only the most experienced subject matter experts (SMEs) who develop and deliver actionable curriculum in a way that stays with the participant.
  • LSTI's training courses focus on the needs of adult learners, blending instruction with interactivity, job aids, and knowledge checks.
  • The learning objectives of each LSTI course are supported by case studies, research, and the latest industry trends.
  • Every training topic is hand-picked based on customer feedback and internal research to ensure that we are addressing the unique needs of today’s GxP professionals.

What Do Past Attendees Have To Say About Our Courses?

“Regulatory trends as a whole are very important to my organization, specifically my department of IT Validation Services and our counterparts in Compliance. So the entire course was useful, especially the "Top 10" info relating to FDA/MHRA findings. This type of information could influence the direction we take to validate systems and enforce our own compliance. The content and presenter were very good, and the user interface including polling questions were great and very easy to use."
-Kevin B., Bristol-Myers Squibb

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-Amy C., Mallinckrodt Pharmaceuticals 

“The most useful part was learning what the trends are and finding out where others are in the journey. The information about RCA and also the information on training and knowing that your employees are trained makes for compelling arguments on what we need to do better in management. Looking forward to reading the white paper.
-Carol L., Reckitt Benckiser


Duration: 90-Minutes - Online

Price: $279 - Includes Bonus Handouts!