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Understanding Intended Use from ISO TR 24971:2020 - Featured Image

Understanding Intended Use from ISO TR 24971:2020

If you haven’t yet got into ISO TIR 24971:2020, there’s a fair bit to read up on.
How the MDSAP Grading System Works - Featured Image

How the MDSAP Grading System Works

The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...
How MHRA is Regulating Medical Devices in the UK after Brexit - Featured Image

How MHRA is Regulating Medical Devices in the UK after Brexit

If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in ...
Recruiting Top Medical Device Talent in a Competitive Market - Featured Image

Recruiting Top Medical Device Talent in a Competitive Market

While robust growth in the medical device industry has seen more people coming into the field, it’s ...
How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation - Featured Image

How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation

Clinical investigations play an important role in your journey of bringing a medical device to marke...
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...

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