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How FDA Distinguishes Between Clearance vs. Approval vs. Granted - Featured Image

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

As a medical device professional, you are well aware of how much time and effort goes into getting y...
C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS) - Featured Image

C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS)

  Experienced medical device professionals can agree that investing in quality early on and putting ...
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? - Featured Image

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...
7 Tips to Attract Investors and Raise Funds for your Medical Device - Featured Image

7 Tips to Attract Investors and Raise Funds for your Medical Device

Is your medical device company in the midst of raising funds or planning to begin the process? There...
Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device - Featured Image

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers,...
5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company - Featured Image

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

As a medical device manufacturer, your quality management system is the heart of your operations. 
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them) - Featured Image

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

Effective planning is the key to success for any business but to an even greater degree in the medic...
Leveraging Technology and Rapid Prototyping Methodologies during Product Development - Featured Image

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Do you know everything there is to know about prototyping, product iteration, and manufacturing to g...
Complete Guide to Bringing a Medical Device to Market - Featured Image

Complete Guide to Bringing a Medical Device to Market

Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

Design verification can be a difficult stage for medical device companies to carry out effectively. ...

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