Product Development and Engineering for Medical Devices (Level 3)

Product Development and Engineering for Medical Devices (Level 3)

Now that you're starting to get a feel for things let's dive deeper. This combination of guides, courses, and webinars will have you feeling ready for any product development challenge as you make your way to your Expert Badge.

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A Step-By-Step Guide to Preparing your FDA 510(k) Submission
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
Get ready to submit your 510(k) with advice from our industry experts
Document Management Design Controls Change Management Device Classification QMS 510(k) Product Development QMS Refinement & Regulatory Submissions Advance Exclusive eBook

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Challenges with Applying Risk Management Throughout the Manufacturing Process
Challenges with Applying Risk Management Throughout the Manufacturing Process
Every medical device developer has to understand risk management. You could learn the hard way, or you could listen to our experts share their trials and successes on this important topic.
Risk Management ISO 14971 manufacturing Product Development Product Launch Post-Market Surveillance Advance Exclusive Podcast

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Design Controls, Development, and Risk for SaMD
Design Controls, Development, and Risk for SaMD
Many elements of medical device development are different for software devices. Learn the key differentiators and best practices for developing these exciting device types.
Risk Management Design Controls SAMD Ideation & Prototyping Product Development Advance Exclusive Podcast

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From Self-Declaration to Certification: Proving Performance Under IVDR
From Self-Declaration to Certification: Proving Performance Under IVDR
Learn best practices around proving performance under the new IVDR requirements.
0 hr 54 min
Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar

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How to Create Medical Device Labels per EU MDR
How to Create Medical Device Labels per EU MDR
A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device
0 hr 55 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Advance Exclusive Webinar

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How to Meet Cybersecurity Requirements of EU MDR & IVDR
How to Meet Cybersecurity Requirements of EU MDR & IVDR
EU MDR and IVDR are changing and cybersecurity requirements are no exception. Get the details in this important discussion with Justin from TUV SUD.
0 hr 54 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar

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Risk Management According to EU MDR or ISO 14971?
Risk Management According to EU MDR or ISO 14971?
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 53 min
ISO 14971 Regulatory Management Ideation & Prototyping Product Development QMS Refinement & Regulatory Submissions Product Launch Standard (Free)

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The Art of Defining Design Inputs and Design Outputs
The Art of Defining Design Inputs and Design Outputs
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
Design Controls QMS Product Development Advance Exclusive eBook

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The Beginners Guide to Design Verification and Design Validation for Medical Devices
The Beginners Guide to Design Verification and Design Validation for Medical Devices
In this guide, we’ll go through the basics of design verification, design validation, best practices you should deploy, pitfalls you should avoid, and plans that will make it all come together.
Design Controls Product Development QMS Refinement & Regulatory Submissions Advance Exclusive eBook

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The Risk Management + Design Controls Connection: What Device Makers Need to Know
The Risk Management + Design Controls Connection: What Device Makers Need to Know
Greenlight Guru found Jon Speer discusses why design controls and risk management should flow and blend together, and it’s important to establish this flow early in product development.
Risk Management Design Controls Product Development Standard (Free) eBook

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Product Development and Engineering Checkpoint Charlie
Product Development and Engineering Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Advance Exclusive

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