Market Entry for Food Products and Supplements in Latin America: Navigating Regulatory Challenges

Medical Device
Upcoming Webinar

Aligning supplier evaluation practices with US FDA and ISO 13485 requirements 

6th March 2025 

45 Minutes

Join the Webinar as per Your Time Zone

For AMR & EU Regions

9:00 AM EST | 3:00 PM CET

Register Now

For RoW Region

11:30 AM IST

Register Now

What is it all about?

In the highly regulated medical device industry, adherence to global standards such as 21CFR820 and ISO 13485 is imperative for compliance and maintaining competitive advantage. These standards govern the quality management systems (QMS) and Regulatory expectations for medical device manufacturers and suppliers. Effective supplier management is critical to these QMS standards, impacting everything from production to final product safety.

The webinar will be hosted by Sugandha Gupta- Lead Strategy Consultant, MDV Freyr Solutions and presented by Anuradha Gore- Senior Manager MDV, QMS team Freyr Solutions

In brief, the topics to be discussed during the webinar include: 

  • Introduction and Overview of Supplier Evaluation
  • Understanding the requirements of ISO 13485 & 21 CFR 820 for Supplier Evaluation & Control
  • How to do Supplier evaluation
  • Documentation for Supplier evaluation
  • FAQs
  • Wrap up of the session

Given the keynotes and with due consideration for your hectic schedule, we anticipate seeing you in the webinar. Register now! Stay informed. Stay compliant.
 

For more information on compliance best practices, write to us at contactus@freyrsolutions.com.

 

Hosted By

Sugandha Gupta

- Lead Strategy Consultant, MDV Freyr Solutions

  

Sugandha Gupta is an accomplished Strategy Consultant specializing in the Medical Device, SaMD  and IVD domains. Her commitment lies in delivering comprehensive end-to-end regulatory solutions, guiding organizations through complex compliance landscapes for successful market access and global expansion.

Sugandha excels in crafting tailored regulatory strategies that cater to the unique needs of healthcare industry stakeholders. She adeptly navigates organizations through intricate compliance requirements, ensuring seamless transitions and strategic implementations.

 

Presented By

Anuradha Gore

- Senior Manager MDV, QMS team Freyr Solutions

  

Anuradha Gore, a seasoned Senior Manager at Freyr. With an overall experience of 18+ years in Biotechnology and Medical device industry, she serves as a QMS Subject Matter Expert, certified LEAs Auditor for ISO 13485, ISO 9001, and MDSAP.

Anuradha has an extensive experience with planning strategies and implementation of ISO 13485, ISO 9001, 21 CFR 820 and MDSAP with diverse portfolio of medical devices, IVDs and SaMD.