Medical Device Development Immersion
- May 12, 2021 - May 13, 2021
- (Time : 12:00 pm - 06:30 pm EDT)
- Price : Not available - SOLD OUT
- Instructor Name: Jim Macemon
- Course Level: Level 1 - Foundational
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Medical Device Development Immersion is an interactive, two-day preparatory course designed for those who need to better understand all aspects of medical device development. Beginning with an overview of the medical device industry, the course quickly delves into the changing regulatory environment and the different regulatory pathways devices can undertake for FDA or EMA marketing approval. Attention is then focused on a detailed explanation of the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course ends with a brief look at commercialization, including reimbursement strategies. Learn from an industry expert with 30-years of experience in both large and start-up medical device companies.
Anyone who works in medicine, engineering, finance, legal, marketing, business development, project management, IT, administrative support, quality assurance, regulatory affairs, and manufacturing.
- Fluency in the essential terminology and acronyms used in the medical device sector.
- Improved communication with engineers, regulators, colleagues, and clients.
- Ability to construct a medical device by following the traditional five phases of development.
- Understanding of the medical device approval pathways in both the USA and European Union.
- Conduct risk mitigation during medical device development.
Course Delivery: All master courses are presented on Zoom.
To view your master course:
1. Log into your Biotech Primer account in the upper right-hand corner of biotechprimer.com.
2. Once logged in go to “My Profile”.
3. Go to "User Dashboard" found in the dropdown menu under "My Profile" link.
4. Click on the class name.
5. Click on "View Course".
6. The Zoom link is available 15 minutes before the course begins.
Course Materials: Each master course comes with a downloadable workbook that includes all presented materials. The workbook is available on your “User Dashboard” under “Course Materials”. Please note each workbook is proprietary and is not to be shared with others.
Course Recording: All live, online master courses are recorded and those recordings are made available to registrants for two weeks. So if you cannot attend the course for the entire day or you simply would like to review the content, you can rewatch the course as often as you'd like within the two week timeframe.
Course Certificate: Once you complete your master course, you can download your course certificate from your “User Dashboard”. You may also post your certificate on your LinkedIn page or list our Biotech Primer class in your LinkedIn education profile by following the “Share” button found next to your certificate.
Refund Policy: All courses and products are final sale. If you cannot attend a course, you may send someone in your place by notifying us at info@biotechprimer.com a minimum of five business days prior to the start of the master course so the ZOOM link and certificate can be reset.
Questions? Contact us at info@biotechprimer.com
Interested in having a customized master course delivered in-house to your team? Contact Stacey Hawkins at stacey@biotechprimer.com
All master courses are presented on Zoom.
To view your master course:
1. Log into your Biotech Primer account in the upper right-hand corner of biotechprimer.com.
2. Once logged in go to “My Profile”.
3. Go to "User Dashboard" found in the dropdown menu under "My Profile" link.
4. Click on the class name.
5. Click on "View Course".
6. The Zoom link is available 15 minutes before the course begins.
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.
All master courses begin at 9:00am; the Zoom link is avaiable starting at 8:45am. Please check your master course schedule to determine if the class is running on eastern time zone or pacific time zone. There are 10-15-minute breaks between each section and a 45-minute break for lunch. The course ends around 3:30pm.
You need a computer with internet access and a built-in mic or headphones.
All course materials are kept on your Biotech Primer dashboard. Course materials 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.
Each master course comes with a downloadable workbook that includes all presented materials. The workbook is available on your “User Dashboard” under “Course Materials”. Please note each workbook is proprietary and is not to be shared with others.
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 requires only our signature to receive credit hours we are happy to sign your document.
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 us at This email address is being protected from spambots. You need JavaScript enabled to view it. a minimum of five business days prior to the start of the master course so the ZOOM link and certificate can be reset.
