Medical Device Development Immersion
- May 12, 2021 - May 13, 2021
- Time : 12:00 pm - 06:30 pm EST
- Price : $995 USD
- Instructor Name: JIm Macemon
- Course Level: Level 1 - Foundational
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Medical Device Development Immersion is a ten-hour course that surveys all aspects of medical device development. Learn about the changing regulatory environment and compare the United States and European Union approval processes. Discover in detail the five phases of medical device development: market opportunity, evaluation, design, verification, and manufacturing. Take this course to develop an understanding of the entire process required to bring a new medical device to market.
Anyone who works in medicine, engineering, finance, legal, marketing, business development, project management, IT, administrative support, quality assurance, regulatory affairs, and manufacturing.
- An improved ability to communicate with engineers, colleagues and manufacturers.
- Fluency in medical device terminology and processes.
- A toolbox to help design a medical device prototype.
- Knowledge of the various approval pathways for each medical device class.
- Risk mitigation in medical device development and approval.
Course Delivery:
All instructor-led virtual courses will be presented on Zoom. To access the course on Zoom, log into your Biotech Primer account in the upper right-hand corner of the website. Your username is your email address you registered with; your password was sent to you in an email upon registration. If you cannot find this registration confirmation email, reset your password on the login page. Once logged in, go to "User Dashboard" found in the dropdown box under your "My Profile" link. The Zoom link will be available 5 minutes before the course begins. Click on the orange "View Course" button and enjoy your course.
Course Materials:
Course materials will be available on your dashboard. You will be given access to a portal where you will be able to view the course materials. Please note the course material will remain on the Biotech Primer portal and you will not be able to download or print these materials. However, you will have access to these materials whenever you log into your Biotech Primer account.
Course Certificate:
Once you have completed your course, your certificate will be available on your dashboard.
Breaks:
There will be a 10-15-minute break between each section. You will be given a 45-minute break for lunch.
Refund Policy: All courses and products are final sale. If you cannot attend a course, you may send someone in your place by notifying Emily Sullivan at sullivan@biotechprimer.com no later than one week prior to the start of the class as the Zoom account will need to be reset.
Questions?
For this course: Emily Sullivan sullivan@biotechprimer.com
Customized training questions: Stacey Hawkins stacey@biotechprimer.com
All instructor-led virtual courses will be presented on Zoom. To access the course on Zoom, log into your Biotech Primer account in the upper right-hand corner of the website with the username and password you chose when you registered for the course. Once logged in, go to "User Dashboard" found in the dropdown box under your "My Profile" link. The Zoom link will be available 5 minutes before the course begins. Click on the orange "View Course" button and enjoy your course.
Our ideal number of participants is 25-35.
We have a diverse audience in experience, education, and job description. Attendees range from C-level executives to manufacturing shift-workers; those new to the industry to season veterans who may find themselves in a different position or with a new company. This mixed of backgrounds extends the learning for all since everyone has something to contribute to and learn from the group.
The class begins promptly at 9:00am. There will be a 10-15-minute break between each section. You will be given a 45-minute break for lunch. Classes end at 3:30pm.
You need a computer with internet access and a built-in mic or headphones.
All course materials are kept on the Biotech Primer portal which you will have access to indefinitely. Course materials may include an electronic PDF copy of all presented slides and activities; some courses include a glossary of biotech terms or a list of commonly used acronyms.
No pre-work is assigned.
Once you register for a class, course material is available on your Biotech Primer account dashboard. You are given access to a portal where you are able to view the course materials. Please note the course material will remain on the Biotech Primer portal and you will not be able to download or print these materials. However, you will have access to these materials whenever you log into your Biotech Primer account.
Our instructors are dynamic, industry-experienced experts. In fact, this is what sets us apart from other training organizations – our instructors! Anyone can “learn the presentation”- but our instructors can handle your most difficult questions. Our engaging Biotech Primer instructors “edu-tain” you with their own personal war stories.
We do not provide credit hours, however if an organization has access to accreditation, we are certainly willing to sign needed documents to get someone their credit hours.
Once you have completed your course, your certificate will be available on your dashboard.
All courses and products are final sale. If you cannot attend a course, you may send someone in your place by notifying Emily Sullivan at This email address is being protected from spambots. You need JavaScript enabled to view it. no later than one week prior to the start of the class as the Zoom account will need to be reset.
Medical Device Development Immersion