Jay spent 26 years at the FDA, and he developed the requirements for the FDA's UDI system and was one of the authors of the US UDI rule. Jay explains what the delay of enforcement for some class I devices in the US means.

Jay Crowley, VP and UDI Practice Lead at USDM Life Science

What we talked about:

• What are the details of the new UDI and MDR requirements 
• Determining your organization's requirements
• Strategies to implement adapted practices

Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website.

He's an accomplished life sciences, regulatory and ISDN compliance professional. With more than 25 years of experience in the pharmaceutical medical device, biotech and blood management industries, specifically in the fields of computer systems, validation, risk management, and quality assurance, software development, product, life cycle management, and compliance roadmap development.

David Blewitt, Vice President of Cloud Compliance, USDM Life Sciences

What we talked about:

• Cloud usage in Life Sciences
• New applications for usage
• Adapting to conducting business in a COVID 19 environment

Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website.

7 year Life Sciences industry veteran, Ryan Carmel, Marketing Director at USDM, will host a brand new podcast bringing relevant and educational peer content to the people within the life sciences industry.

Well versed in the unique business challenges, and more recently helping organizations with the immediate need to fast-track their digital transformation in light of COVID-19, USDM has become a trusted advisor to many regulated pharma, medical device, and biotech firms, and now, cannabis companies. 

With 20 years of consulting in this space, USDM Life Sciences’ depth of regulatory and FDA expertise this podcast will provide a new, more modern forum to tell stories and share lessons learned, helping life sciences companies with their challenges.

What we talked about:

• Launching “Life Sciences Accelerated” w/ host Ryan Carmel
• Regulatory and FDA consulting expertise 
• Unique business challenges in the Life Sciences industry

Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website.