Design Control for the Medical Device Industry
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Course
0705
-
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
- What the FDA expects now
- A detailed look at requirements
- Issues that impact Design Control
- EU Directive (CE Mark) requirements
- Risk Analysis
- How to create a CE Marking technical file
- How to compile a design dossier
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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 course provides the information needed to meet the required regulations driven by ISO 9001, QSR and the European Medical Device Directives. Learn how to deal with the cultural and business issues that impact Design Control activities. Attendees will gain a thorough understanding of: The need for Design Control; Similarities and differences between ISO 9001, ISO 13485, and QSR; Documentation and required records; How to establish a simple model for new product design development; Technical file and risk analysis; What inspectional strategies are used by the FDA.
Course Benefits Include:
- Understand how to meet QSR requirements for Design Control
- Keep documentation to a minimum, while still meeting requirements
- Bring new or enhanced products to market faster
- Demonstrate to regulatory agencies that products are developed under a controlled process, assuring safety and effectiveness
- Minimize product liability related risks
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
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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