Quality System Regulations (QSR) for the Medical Device Industry
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Course
0707
-
2
Days
-
1.4
CEUs
$995 USD
$895 USD with 30-Day Prepay Savings
$497 USD for Third Attendee
$447 USD for Third Attendee with 30-Day Prepay Savings
Save 10% to 30% in our Customer Rewards Program
Key Session Topics
- Explanation of the Quality System Regulation (QSR)
- How TC 210 affects change within the medical device industry
- Harmonization with international regulations
- How to make the transition into a tiered quality system
- Relationship between ISO 9000/ISO 13485 and the European Union’s CE Marking requirements
- How the guidance documents relate to the requirements
- Timelines for compliance
- Overview of Design Control
- FDA’s expectations of Product Safety
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Why SAI Global?
- Our courses teach real-world business objectives in an
interactive learning environment.
- Our instructors have an average of 20 years industry experience.
- We offer excellent customer service.
- We have maintained a 98.9% approval rating among more than 200,000
training participants.
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Dates, Locations,
and Registration
You can register for a course in either of two easy ways:
- Call us at (800)374-3818.
- Click on a date in the table below and complete the online registration form.
Register online or call 800-374-3818.
If you have questions about this course,
submit a
Course Information
Request
or call us at 1-800-374-3818.
To learn about the savings and instructional benefits of training five or more participants
at your location, submit an
On-Site Quote Request
or call us at 1-800-374-3818.
To learn how you can save 10% - 30% on course registrations with SAI Global as your preferred training provider, submit a
Customer Rewards Request or call us at 1-800-374-3818.
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Course Objectives
This two-day course is designed to give you the most updated information on the FDA requirements for the QSR and product safety. Case studies, workshops and interactive discussions are used throughout the sessions to demonstrate how these new regulations affect you and your business.
Course Benefits Include:
- Understand the FDA’s regulatory history affecting medical devices manufactured for use in the
- United States
- Learn about the FDA’s objective to harmonize US medical device regulations with the international community
- Review standards such as risk analysis and guidance documents
- Learn inspectional strategies used by the FDA
Who Should Attend
- R&D managers/engineers
- RA/QA managers/engineers
- Management representatives
- Members of multi-discipline design teams
- Sales and marketing management
- Product, project, program managers
- Internal auditors
- Purchasing managers
Prerequisites
There are no specific prerequisites for this course.
What's
Included in the Price
The course price includes:
- breakfast, lunch, and refreshments each course day -- special dietary needs are
no problem
- a student manual developed by experienced instructional designers
- a copy of the standard (where applicable)
- forms, templates, and worksheets for use back at the workplace (for auditing and
other applicable courses)
- certificates upon completion of course requirements
Hotels:
Although hotel reservations and accommodations are not included in the course price,
we do secure discounted room rates for most of our courses.
Training at Your Location:
Please contact us at 1-800-374-3818 for information about on-site pricing.
Support from Registration through Certificate of Completion
At every step of the public course process, the SAI Global Customer Relations team
is singularly committed to providing an unparalleled level of support so you can
focus on the learning event instead of on preparations and logistics.
- Once you register for a course by phone, by fax, or online, we send you a registration
confirmation e-mail.
- Approximately 3 weeks prior to the course, or if you register closer to the start
date, we mail and/or e-mail you precourse materials, if applicable.
- If any changes to course/hotel location occur, we contact you immediately.
- Approximately 2 weeks prior to the course start date, we e-mail you a course reminder
to confirm your attendance.
- For the course itself, we provide everything you need to facilitate your learning
experience.
- At the conclusion of the course, the instructor submits test scores (where applicable)
and other necessary paperwork to the home office for processing.
- You receive a certificate of completion and confirmation of continuing education
units (CEUs) earned.
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