Regulatory

How to Enhance your Medical Device Approval Process: Interview with Sheila Heyer, President of Heyer Regulatory Solutions

We all know relationships matter.  They matter at work.  They matter at home. But are relationships important when it comes to getting medical devices approved through the FDA? Beyond relationships, what else matters when it comes to improving the medical device regulatory process? In this interview with Sheila Heyer, President of Heyer Regulatory Solutions, we learn where medical device companies are missing the mark when it comes to the FDA approval process.

Prior to staring Heyer Regulatory Solutions, Sheila’s most recent position was the VP of Global Regulatory Affairs for Boston Scientific.

Interview Highlights with Sheila Heyer

  • The 3 most important steps you can take right now to get your medical device approved faster.
  • Quality submissions and solid relationships: the importance of honing these 2 concepts in order to enhance your medical device regulatory approval process.
  • What characteristics do great medical device regulatory professionals all have in common?
  • How can the FDA and industry work together to improve the regulatory process for medical devices?
  • Sheila’s impressive medical device career and why she still loves this space.

Who is Sheila Heyer?

Sheila Heyer is the President of Heyer Regulatory Solutions.  Prior to starting Heyer Regulatory Solutions, Sheila was the Vice President of Global Regulatory Affairs for Boston Scientific. Prior to her career at Boston Scientific, Sheila spent over 15 years with Medical Device Consultants (MDCI).

Listen to the Interview with Sheila Heyer

Read the Interview with Sheila Heyer

Download a copy of the interview transcript right here.

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