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Get an overview of quality systems and understand the what and why founders need to know. 

Developing a business-centric Quality Management System (QMS) involving all the aspects of an organization can make the difference between success and failure.  Quality plays a huge role, especially for those requiring FDA approval or ISO certification. Most company founders do not know their exact position in the regulatory pathway, and the need to build a strong quality culture begins very early. Missing quality processes along the way can mean long delays in FDA approval, especially since companies will be required to go back and update their quality systems. Delays mean a loss of money and could mean the loss of being first to market. This course is for founders. It provides an overview of quality systems and the what and why you, as a founder, need to understand your responsibility regarding the QMS pathway.

Course Details: 

  • Made with founders in mind. It provides an overview of quality systems and the what and why you, as a founder, need to understand your responsibility regarding the QMS pathway.
  • 6-weeks of alternating virtual group and one-on-one sessions with a Subject Matter Expert. The one-on-ones follow the group learning so specifics of your company can be discussed.
  • The cost is $400 for the course and includes videos from experienced consultants, worksheets, and resources to support your Quality Management System execution.

NEXT COURSE STARTS - SEPTEMBER 14, 2023 THROUGH OCTOBER 19, 2023

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Rahul Rao

Rahul Rao, a distinguished med-tech leader with 17+ years of experience in startups and multinational corporations, specializes in quality systems and NPD engineering. With a strong track record in renowned organizations such as Southwest Research Institute, Gore Medical, Ulthera, Verve Medical, etc., Rahul empowers early-stage ventures as CEO of Desert Platforms Medical Device Consultancy. As an advisor at the Center for Entrepreneurial Innovation, he shares expertise in building robust Quality Management Systems for regulatory compliance. Rahul's dedication to quality-focused initiatives helps med-tech organizations improve patient outcomes and achieve excellence in quality engineering and R&D.

WEEK ONE- THE FOUNDATIONS

  • Building a Quality Culture
  • What is Quality and what is a Quality Management System (QMS)?
  • The Founders Responsibilities
  • Documenting your QMS

WEEK TWO- LEADING THE REGULATORY AND QUALITY MANAGEMENT SYSTEM JOURNEY

  • Understand that Regulatory Requirements are Separate but Related to the Quality system
  • Medical Device Classifications
  • QMS Implementation - The Phased Approach
  • Resources and Budget Plan

WEEK THREE - BUILDING ORGANIZATIONAL CAPACITY 

  • Business Based QMS
  • Transfer to Manufacturing Process
  • Go to Market Process
  • FDA Warning or Recall
  • Post Market
  • Hiring a QMS Consultant
  • ISO Registrar

Interested in participating? Carly Figman can provide details about pricing, when it's happening, and how to sign up. Reach out today for more info! 

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Carly Figman

Community Engagement Coordinator

carly.figman@ceigateway.com