Medical Device Development to Market Under Design Control

Medical Device Development to Market Under Design Control

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The steps necessary to bring a medical device to market under the US FDA's Design Control and the CGMPs

About this event

Date: Aug 24-24, 2022.

Time: 12 PM ET to 4 PM ET

Duration: 2 day - 8 total hours, 4 hrs./ day.

Level: Intermediate to Advanced

The FDA expects companies to manage new product development projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards. How can the FDA's Design Control requirements, 21 CFR 820.30, C8actually facilitate this? The EU MDR and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not committed until late in the project when disaster looms? How to minimize scope creep? How to conclude a project "on time" and "within budget"? What are all the steps to get a product from conception to market, while adhering to the regulatory requirements in the US and EU? How to gain management support for the Milestones, Tasks, Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. Growing high-profile field problems indicate that much project management is poor or non-existant. Buy up-front time for proper project planning. These techniques are not rocket-science, but require the implementation of formal methods with documented, and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan" with all stakeholders.

Areas Covered in the Session:

Day 1:

  • Design Control requirements (US and EU)
  • Meet Key Requirements of the CGMPs/ISO with Formal Project Mgmt.
  • The Three Most Common PM Tools - Gantt, CPM, PERT
  • Work Breakdown Structure, Reverse Engineering, Milestones, Tasks
  • Suggested Design Control Project Management Templates

Day 2:

  • The Device CGMPs
  • The 510(k) (FDA clearance) and PMA (FDA approval) and alternatives
  • EU MDR considerations
  • CE-marking

Who will benefit: The designations

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in project management tools and techniques targeted specifically to the regulated medical products industries, under cGMP and MDD/CE-marking compliance. It will discuss and provide examples of the most common project management tools and provide a major example for immediate use. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • R&D and Engineering
  • All personnel tasked with any project management and new product development, and those who soon hope to be

Target Companies: (Examples)

Pfizer, Abbott, Hospira, J&J, Cardinal, Integra, GlaxoSmithKline, Merck & Co., Bayer etc….

Target Association:

RAPS, ASQ, et al

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

  • In-Person Seminar going Virtual with increased learner satisfaction.
  • Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:
  • Our enhanced delivery process and technology provides you with an immersive experience and will allow you to access:
  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at different times and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding

Personalized Training:

The customized training will give you the advantage to do training according to your time and date and the sessions are interactive with a long Q&A session with more in-depth content purely customized for your organization. Want to do a new lab setup, audits, or knowledge on a specific topic. The content of the training will be modified after analyzing your data. We will arrange a call for you and the expert in which you will discuss the areas where your team faces issues and the speaker will design the content accordingly. In addition, personalized sessions give you the opportunity to discuss off-topic issues with our experts.


Unlimited participants, Recordings to all the participants with lifetime access, Materials, Certificates, and long Q&A sessions.

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