US medical device development personnel - mainly medical device designers and engineers
This 2-day virtual course discusses and explains standards, regulations and guidance that medical device manufacturers in the US need to be aware of and comply with when exporting medical devices to the European Union (EU). The course includes FDA regulations that US medical device manufacturers must meet to market their products in the US and the specific standards and regulations set by the EU for device import.
- CEU Hours: 1.3
- Length: 13 Hours
- ASQ RU: 1.3
- Audience: Practitioner
- Provider: WebEx Training
- Definition and Classification of Medical Devices
- EU Directive
- Exporting Requirements from FDA
- Importing Requirements to EU
- Relationship Between ISO 13485 and 21 CFR 820
- Process Design and Development (Overview)
- ISO 10993 Biocompatibility
- Software Development for Medical Devices
Who Should Attend
U.S. medical device development personnel; mainly medical device designers and engineers, and managers responsible for exporting their products who must know the standards and regulations to integrate into their medical devices and complete the paperwork to make their medical devices FDA and EU compliant.
- Understand the different classifications of medical devices.
- Recognize the differences between device classes in the US and the EU.
- Determine the appropriate class of a medical device.
- Become familiar with the essential elements of the EU medical device directives such as MDD 93/42/EEC.
- Understand and apply FDA export requirements such as 21CFR 801, 802, 803, 807, 510(k) marketing clearance, Exporting unapproved devices, Export certificate, etc.
- Understand and apply import requirements to EU (CE marking).
- Examine the relationship between ISO 13485 and 21 CFR 820.
- Analyze process design and development in terms of timing, personnel involved, process capability and validation, monitoring, etc.
- Understand and utilize the pertinent elements of GHTF guidance such as risk management, QMS definition, and auditing.
- Apply ISO 10993 for biocompatibility assessments.
- Understand and apply ISO 11607:2006 for sterilization of medical devices.
- Distinguish between medical device reporting requirements in the US and EU.
- Comprehend and implement standards and regulations pertaining to software development such as ANSI/AAMI/IEC 62304, IEC 12207, and AAMI TIR 32.
After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.
- Computer – PC or Macintosh
- High-speed internet connection
- Adobe Flash Player 10.3 or later
- Windows: Internet Explorer 8 or later, Google Chrome (latest version), Firefox (latest version)
- Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)
- For instructor-led virtual WebEx courses, a speakerphone or telephone headset in a designated room or space with no distractions (preferred)
NOTE: Refer to product description for any additional system requirements.
WebEx – Virtual Course: Advance Preparation and Student Information
Join a Test Session
We strongly suggest that you join a WebEx test session in advance of your scheduled virtual training, using your preferred web browser. This can help prevent problems launching content the day your training begins.
If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.
To join a test session (meeting), click here and enter your name and email address to join. If successful, you will see a screen that says "Congratulations! Your system is now set up properly ..."
Deactivate Pop-up Blockers
You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.
- If you need to cancel, we will refund your paid registration fee as noted below.
- Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
- Requests received within 5 business days of the course starting incur a $150 processing fee.
- After the course starts, there are no refunds or transfers.
- Registrants who fail to attend without advance notice are liable for the entire course fee.
- If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
- You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
An Internet-based, instructor led course utilizing web and teleconferencing technologies to allow students to interact without traveling. Virtual courses offer interaction with instructor and students via phone and Internet capabilities. Students have access to interaction both with the instructor and other students in an Internet-based learning environment (white board, Q&A tools, application sharing, and breakout rooms). Virtual courses are classroom-like experiences offered using the latest Internet tools.
|No Offerings Scheduled||English||List: $899 Member: $799|
ON-SITE TRAINING FOR YOUR ORGANIZATION.
ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.
5 Benefits of On-Site Training
- Expertise to your location: Saves time and travel expenses
- Convenient scheduling: Train groups of five or more
- Customizable courses: Training tailored to your groups’ needs
- Immediate results: Employees complete courses ready to apply what they’ve learned
- Value-add support: Instructors available to answer questions after session