Toll Free: +1-888-717-2436


Your Shopping Cart

Contains 0 items
Total: $0.00
View Shopping Cart
Cart Image

Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar

Stan Mastrangelo, Consultant
Salt Lake City, UT
| Thursday, December 15, 2016 | Friday, December 16, 2016

Course Description:

The course is designed for Medical Products Manufacturers. The course will be taught for Medical Devices and Combination Products, but will also be of benefit to Pharmaceutical Manufacturers.

Learning Objectives:

Upon completion of the course, the participants will have learned how to implement good risk management principles into medical products manufacturing operations such as medical devices, combination products, and pharmaceuticals:

  • Understand what are the current issues and recommended solutions
  • How to implement the ISO 14971 framework
  • Use a Traceability Report for improved risk management operations
  • How to Use Standards to Facilitate Product-to-Market Achievements
  • How to Use Risk Management to Identify the Critical Success Factors
  • Key implementation issues related to Risk Management
  • Using Risk Management to identify key opportunities for the organization
  • Risk Integration Issues, especially related to the Quality System and Design Controls
  • Use of appropriate risk management tools beyond FMEA

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will benefit:

The course is designed for manufacturing professional employees that must interface with or implement product risk management activities in a medical product manufacturing operation.

  • Product Risk Managers
  • Quality Assurance
  • Regulatory Affairs
  • Research & Development
  • Project Managers
  • Operations Managers
  • Manufacturing Managers
  • Engineers

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Introduction to Risk Science
    • What Is So Special About Medical Products?
    • Complexity Theory, Chaos Theory, and Decision-making
  2. Introduction to ISO 14971
    • What it is
    • What it isn’t
  3. What Is New?
    • New European Requirements
    • Risk Management in IEC 60601
    • Human Factors
  4. Frameworks for Successful Risk Management
    • Review of ISO 31000
    • Combination Products and ICH Q9
  5. Planning for Effective Risk Management
    • Integrating Risk Management into Design Controls
    • Risk Concepts in Project Planning
  6. The Master Document – The Traceability Report
    • Key role of this document
    • Leverage this report to meet new EN requirements
  7. ISO 14971 - By The Numbers
    • Management Responsibility
    • Risk Policy
    • Establishing Risk Acceptability Criteria
  8. Risk Analysis
    • The Importance of Preliminary Hazard Analysis
    • Risk Estimation – Effective Use of Qualitative Analysis
    • Using More Tools Than Just FMEA

  1. Risk Assessments
    • Using a Modular Strategy for Complex Products
    • How to Assess Overall Risk and Risk-Benefit
  2. Risk Control Techniques
    • Verification of Implementation
    • Using Validation for Effectiveness
  3. Production & Post – Production
    • Is Production Being Monitored and Documented in the Risk File?
    • Documenting Field Performance in the Risk File
    • Making Recall Decisions
    • Communicating Risk to Stakeholders
  4. Risk Management in R&D
    • Risk Science in the Research Phase
    • Risk Management in Design Phase Reviews
  5. Risk Management in IEC 60601, Third Edition
    • Using Risk Science to Address Unique Product Characteristics
    • The Test Lab and the Risk Management File
  6. Risk Management in the Supply Chain
    • Assessing Supply Chain Risk
    • Controlling Supply Chain Risk
  7. Organization of the Risk Management File
    • Product Families
    • Products and Accessories in Medical Systems
  8. Conclusion
    • Confirmation of Learning Objectives
    • Key Topics to Watch

Meet Your Instructor

Stan Mastrangelo

Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee for the IECEE.

Register Online


Seminar One Registration

December 15-16, 2016, Salt Lake City, UT
(For Registrations till October 15, 2016 - $1699)
(For Registrations till November 25, 2016 - $1899)
(For Registrations after November 25, 2016 - $2199)


Seminar One Registration (With 2 Nights Stay)

December 15-16, 2016, Salt Lake City, UT

You Save: $1,597.00 (23%)*

Special Group Discount Register for four attendees

December 15-16, 2016, Salt Lake City, UT
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.

For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Register by P.O. / Check

Yes, I want to attend "Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Suite 200
Palo Alto, CA 94303

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.



View Larger Map


Well-chosen topics, experienced presenter and excellent support material. In all, a good training experience.
- Manager, Instrument Risk, Abbott Molecular, Inc.

Very useful support material and a good presenter. The course was well structured.
- Senior Project Manager, Risk Management, Abbott Molecular, Inc.

The presenter offered a fresh perspective of the subject.
- Regulatory Affairs Supervisor, Hu-Friedy

The seminar content and presentation were both good.
- Quality Engineer, Hu-Friedy

The topics covered were really helpful and the presenter had a wealth of information to share. The support material provided during the course was useful too.
- Senior Quality Engineer, Harvard Apparatus Regenerative Technology

The presentation was designed well and the presenter was conversant. I found the sessions interactive and well-planned.
- QA Program Engineer II, Abbott Medical Optics Inc.

The topics covered were sound. The group interaction and discussions were helpful.
- Program Engineer III, Abbott Medical Optics Inc.

The course covered everything I thought it would. Overall well presented.
- Lead Compliance Agent, ForeverGreen International

I found the presenter to be very knowledgeable and he spent time covering all the topics effectively. The support material he shared with us was quite useful too. The topics covered and the overall presentation were both sound.
- Regulatory Affairs / Compliance Manager, LSI SOLUTIONS®

Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

Temple Square is Salt Lake City's most popular attraction. With its grand six-spired temple, two visitor's centers, lovely flower gardens and fountains - and nearby sites related to the Church of Jesus Christ of Latter-Day Saints. Area attractions include the Assembly Hall, Tabernacle, Museum of Church History and Art, Family Search Center, Beehive House, Lion House, Brigham Young Historic Park, LDS Conference Center and Joseph Smith Memorial Building. Temple Square offers hundreds of free movies, dramatic programs and music events every year.

The Gateway on the west side of downtown Salt Lake is the city's best outdoor shopping center.

It's designed to be a walkable shopper's paradise, with six acres of green space, the namesake creek, two 18-foot waterfalls, and a massive retractable roof.

The Utah State Capitol, at 300 N. State St., sits atop a hill overlooking the Salt Lake Valley. The building was constructed in 1912-1916 and renovated in 2004-2008.

Utah's Hogle Zoo dates from 1931 and is located at the mouth of Emigration Canyon at 2600 E. Sunnyside Avenue. The Zoo is one of the most visited attractions in Utah and the top paid-for tourist attraction in Salt Lake City. It covers 42 acres and includes more than 800 animals.

This is the Place Heritage Park includes a restored pioneer village with live demonstrations of pioneer life and a restored Brigham Young farmhouse.

The University of Utah is not only one of the state's leading educational institutions but also an important cultural and sports center for the city and the state of Utah.

Liberty Park is Salt Lake City's second largest public park and includes trails, playgrounds, a pond, paddle boat rentals, tennis courts, picnic facilities, amusement rides and a water play area. Liberty Park includes the Chase Home Museum of Folk Arts and the excellent eight-acre Tracy Aviary, one of two free-standing aviaries in the United States.

Library Square, at 210 East 400 South, includes not just the award-winning Salt Lake City main library, but also shops, a cafe, a Salt Lake Community College Writing Center and the studios of KCPW, a local NPR affiliate.

The Kennecott Bingham Canyon Copper Mine in the southwest corner of the Salt Lake Valley is the world's largest man-made hole in the ground and has produced more copper than any other mine in history. It is one of two man-made objects seen from space.

Thanksgiving Point is a huge recreation area near the Point of the Mountain that includes spectacular themed gardens, a farm and agriculture center, movie theaters, an IMAX, shops, restaurants, a golf course, party and reception facilities, and the world's largest indoor dinosaur museum.

Follow us :
We need below information to serve you better