Participants will quickly learn how to apply these insights to new product development, market introduction processes, and managing standards within an organization. Additionally, they will gain key information on effectively participating in the standards development process.

Attendees will have a unique opportunity to engage with FDA representatives and other key stakeholders during the course, fostering a collaborative learning environment.

Upon completing this course, participants will be equipped with information to effectively apply and manage standards for medical devices across the total new product life cycle.    This course also reviews the establishment and on-going management of an organization specific program for identification and gap analysis when standards change.  This ensures compliance to quality system regulations and applicable standards.  

The curriculum leverages interactive learning technologies to enhance participant engagement. It covers the standards development process, relevant terminology, and key standards development organizations. The course also emphasizes meaningful participation in standards committees while representing a member organization.

• Application of standards across the new product introduction process, including required standards for each phase.
• Identifying and prioritizing additional standards based on specific products, processes, or services.
• Differentiating between national, regional, and international standards development organizations.
• Exploring the impact of standards on products and product lines, particularly with the changing regulatory emphasis on harmonized standards.

Interactive case studies and group discussions are integral to the course, fostering a solid understanding of effective standards participation.