• 

  An electrical engineer’s overview of IEC 60601-1 Terminology & Definitions through Annexes

  Electrical Engineer's overview of IEC 60601-1 covering Terminology & Definitions through Annexes. Part 2 of 2 blogs on the topic.

• 

  Electrical Engineer’s Overview of IEC 60601-1 Scope and Normative References

  EE's overview of IEC 60601-1 Scope and Normative References, one of the more important standards that apply during medical device development.

• 

  CE vs China Export Mark Explained – Avoid Costly Mistakes

  CE vs China Export Mark Explained – Discover meanings, regulations and visual layout of the two marks to avoid costly mistakes.

• 

  New US clinical trial information reporting rule starts January 2017

  The final rule for clinical trial information reporting published by US National Institutes of Health and DHHS now includes medical devices.

• 

  7 Benefits of Using Adaptive Design for Clinical Studies

  Adaptive studies can be especially useful in the pivotal stage if there are uncertainties about one or two aspects of the study.

• 

  Will new FDA final rule on symbols for device labels make devices cheaper?

  FDA final rule on symbols is an important step towards global medical device harmonization and hopefully for a decrease in manufacturing costs as well.

• 

  Use standard methods innovatively to secure regulatory approval for medical devices

  Sometimes the best way to secure regulatory approval requires the project manager to build a different box.

• 

  Expedited Access Pathway: timely medical devices for patients with life-threatening conditions

  Expedited Access Pathway (EAP) is promising for timely approval and access to devices for life-threatening or irreversibly debilitating conditions.

• 

  FDA reports faster medical device approval

  Recent report on policies and initiatives claims the FDA device arm (CDRH) medical device approval process is much faster than five years ago.

There are no posts to show