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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...
4 Parts to Interviewing Candidates for Medical Device Roles - Featured Image

4 Parts to Interviewing Candidates for Medical Device Roles

By Nick Tippmann on February 12, 2020
Are you looking to hire medical device professionals? Or, are you a professional seeking new job opp...
5 Tips for Hiring Medical Device Advisors - Featured Image

5 Tips for Hiring Medical Device Advisors

By Nick Tippmann on February 5, 2020
Everybody seeks advice and opinions from others from time to time, even those in the medical device ...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

By Tom Rish on January 12, 2020
It has long been thought that the quickest path to market for medical device manufacturers is to acc...

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