• 

  How Regulators are addressing COVID-19 related Medical Device approvals

  Round-up of how Regulators in the US, Europe, and Canada are addressing COVID-19 related Medical Device approvals by QA/RA specialist.

• 

  FDA Guidance on Non-Clinical Bench Performance Testing Information

  FDA provides a roadmap to follow for premarket submission in their guidance on Content and Format of Non-Clinical Bench Performance Testing.

• 

  Bringing Consistency to the FDA Inspection Process

  Overview of Device Establishment Inspection Processes and Standards Update that establishes uniform processes and standards for FDA Inspection Process.

• 

  510(k) submission: 9 Tips for success

  9 tips for 510(k) submission along with lessons learned from a recent successful experience submitting a medical device to the FDA.

• 

  When do startups need a Quality Management System (QMS)?

  Advice to help companies determine when to start thinking about setting up a Startup Quality Management System.

• 

  The Bleeding Edge and 510(k) approvals

  The Bleeding Edge explains how 510K cleared medical devices are clinically proven to improve patient outcomes and save lives.

• 

  6 benefits of FDA Breakthrough Devices program

  6 benefits mean the FDA program for breakthrough medical devices may be your best regulatory option for novel medical devices.

• 

  Is the FDA Early Feasibility Studies Program right for you?

  FDA’s Early Feasibility Studies Program (EFS) is a great option in early stage development looking to advance your program by gathering data.

• 

  Navigating Medical Device International Regulations

  Proper research and communication with authorities in each country of interest will make Medical Device International Regulations smoother to navigate.

There are no posts to show