MDR NB Common Submission Issues and How to Prevent Them

Fang’s internal processes and checklists have evolved over the last 3 years since we started working...

Class I Devices Under MDR: To NB, Or Not To NB?

Note: The following discussion applies to non-custom, non-investigational medical devices. If you...

Stay Calm and Carry On: What Brexit Means for Your Medical Device

Much has been said about the fast-approaching transition to the Medical Device Regulation (MDR) in E...

Tracy Eberly and Fang Consulting Discuss Choosing the Best Firm for Your Needs

In a field as innovative and diverse as the medical device industry, finding the right consulting fi...

Notified Bodies

With the EU MDR (2017/745) replacing the current MDD (93/42/EEC) in the EU, many changes are on ...