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Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions - Featured Image

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

How a company chooses to establish and maintain their quality system has everything to do with their...
[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

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)

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)

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)

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)

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)

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)

Which quality processes should I establish first when implementing a medical device quality manageme...
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

It has long been thought that the quickest path to market for medical device manufacturers is to acc...
15 Questions to Ask QMS Software Vendors in the Medical Device Industry - Featured Image

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

As a medical device company, you are expected to deliver innovative, life-changing medical device(s)...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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