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How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020
Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

By Jon Speer on February 25, 2020
FDA Form 483 Observations and Warning Letters - What’s the Difference? - Featured Image

FDA Form 483 Observations and Warning Letters - What’s the Difference?

By Jon Speer on February 21, 2020
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory - Featured Image

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

By Nick Tippmann on February 19, 2020
Regulatory is a big deal for medical device companies. Whether it’s a startup or established busines...
7 FDA Pathways to Bring Your Medical Device to Market - Featured Image

7 FDA Pathways to Bring Your Medical Device to Market

By Tom Rish on February 16, 2020
Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...
[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS - Featured Image

[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS

By Jon Speer on February 14, 2020
How can I justify the costs of implementing medical device specific quality management software at m...
[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase) - Featured Image

[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)

By Jon Speer on February 14, 2020
How can I track the effectiveness of my QMS after my medical device goes to market? We'll cover the ...
[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase) - Featured Image

[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)

By Jon Speer on February 14, 2020
Is my QMS ready for the product launch of my medical device? Which quality processes should I implem...
[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase) - Featured Image

[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)

By Jon Speer on February 14, 2020
How can I prepare my QMS to approve my medical device for manufacturing from a design transfer? Lear...
[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase) - Featured Image

[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)

By Jon Speer on February 14, 2020
Which QMS processes should be established during product development? We'll explain how design contr...
[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase) - Featured Image

[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)

By Jon Speer on February 14, 2020
How do I know which regulations apply to my medical device? What should I include in my quality plan...
[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology) - Featured Image

[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology)

By Jon Speer on February 14, 2020
Which quality processes should I establish first when implementing a medical device quality manageme...

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