• 

  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.

• 

  Sketch to Launch commercialization process for medical devices

  Sketch to Launch commercialization process for medical devices guides translational services to the medical industry.

• 

  When to implement your Quality Management System

  Advice, implications and examples for best time to implement a medical device Quality Management System in US, Canada and Europe.

• 

  Meeting with the FDA

  Meeting with the FDA can put almost everybody in the company in panic mode. Benefits of FDA meetings and what to expect.

• 

  Do’s and Don’ts of Medical Device Labeling

  Medical device labeling includes all information provided with the device. Article identifies jurisdictions and associated “do’s and don’ts”.

• 

  Ready for FDA UDI compliance

  UDI compliance: What does that mean for your products and your company? Link to additional information about UDIs on the FDA website.

• 

  Advice from a former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations

  Interview with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations on prep for regulatory submissions.

• 

  StarFish Analysis: Health Canada online publication of Regulatory Decision Summaries (RDS)

  Health Canada has announced online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review.

There are no posts to show