Hundreds of manufacturers across North Carolina answered the call to make personal protective equipment (PPE) for first-line responders and others in need. Although there is still a need for PPE, many manufacturers wonder what will happen when the pandemic ends. We can’t predict if, or when, the high-demand for PPE will subside, but we can help you prepare. 

Join us for the Medical Devices—Developing a Market Expansion Strategy webinar series. We will address your potential concerns surrounding the selling of PPE and other medical devices. Topics will include:

  • How to apply for a 510k from the FDA so you can continue to sell your PPE after the Emergency Use Authorization expires
  • How to implement ISO 13485 so you can sell your PPE internationally 
  • What you need to know about exporting your PPE outside the US

There is no charge to attend these events, but registration is required. After you register, a link to join the webinar will be sent. Please bring your lunch and join us for one or all of our webinars.

 

Schedule of Webinars 

 

EUA has expired…what next? Explanation of the 510K process September 21, 11:00 a.m.-12:00 p.m. EST

No one knows when it will happen, but eventually it will. Learn how to make sure your medical device can continue to be sold in the U.S. once the pandemic is over. In this webinar, Darren Reeves, president of DP Distribution & Consulting, will discuss:

  • What will happen to my devices made during the pandemic but have not yet sold?
  • What must I do for any medical device to continue?
  • What must I do for class II medical devices (e.g., Surgical Masks, N95s and Surgical Gowns)
  • What is a 510(k)?
  • Steps to achieve a 510(k)?
  • How long does it take?
  • What does it cost?

 

How can I implement an ISO 13485 based QMS? October 5, 1:00 p.m.-2:00 p.m. EST

For companies that want to move their management systems to the next level or that want to sell internationally, ISO 13485 is the international standard that may be required.  Most countries will require this certification.  In this webinar, Darren Reeves, president of DP Distribution & Consulting, will discuss what ISO 13485 is and how to get certified.  Topics include:

  • What is ISO 13485?
  • What is the process?
  • What is a notified body?
  • What are the main sections of the standard?
  • How long does it take?
  • How much does it cost?

 

I want to sell my medical device outside of the US. What do I need to know? October 19, 11:00 a.m- 12:00 p.m. EST

You made it through the pandemic. You followed the appropriate U.S. regulatory pathway and achieved any required marketing approvals. You have successfully grown your customer base and are now ready to expand into other markets. How do you do that? In this webinar, Darren Reeves, president of DP Distribution & Consulting, will discuss:

  • Different countries have different rules. What quality system is required?
  • Focus on E.U.
  • What is the MDD/MDR?
  • What is a CE mark?
  • What are the steps to a CE mark?
  • What is an authorized representative?
  • How long does it take?
  • How much does it cost?

 

Webinar Dates: