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FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Would things be simpler in the medical device regulatory space if there was global harmonization acr...
5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device - Featured Image

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea...
What is 21 CFR 812 - Investigational Device Exemption? - Featured Image

What is 21 CFR 812 - Investigational Device Exemption?

Could your medical device qualify for an investigational device exemption (IDE)?
Top Risk Management Tools in the Medical Device Industry - Featured Image

Top Risk Management Tools in the Medical Device Industry

The role of risk management for medical devices is not just a regulatory expectation, it’s a critica...
5 Tips to Improve your Medical Equipment Quality Assurance Activities - Featured Image

5 Tips to Improve your Medical Equipment Quality Assurance Activities

You’ve just finished designing what appears to be the perfect medical device. It accomplishes its pr...
How to Make Your QMS Comply with EU MDR and IVDR - Featured Image

How to Make Your QMS Comply with EU MDR and IVDR

If your company has or is looking to place medical devices on the EU market, you need to know about ...
4 Reasons to Get ISO 27001 Certification - Featured Image

4 Reasons to Get ISO 27001 Certification

The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...
How to Build Medical Device Usability Testing and Validation into Your Quality System - Featured Image

How to Build Medical Device Usability Testing and Validation into Your Quality System

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...
Waterfall vs. Agile: Battle of the Product Development Methodologies - Featured Image

Waterfall vs. Agile: Battle of the Product Development Methodologies

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?
Pivoting Operations to Meet PPE Demand during Pandemic - Featured Image

Pivoting Operations to Meet PPE Demand during Pandemic

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...
What is a Traceability Matrix and How Do I Create One for My Medical Device? - Featured Image

What is a Traceability Matrix and How Do I Create One for My Medical Device?

You’ve probably heard a traceability matrix is something you need as part of your medical device QMS...
Building a Startup in the MedTech Industry - Featured Image

Building a Startup in the MedTech Industry

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and th...

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