The Center for Entrepreneurial Innovation is a bio and life science incubator, so we write about the numerous horror stories we’ve heard from our interactions with bio founders about the severe consequences that arise when founders overlook the importance of implementing a quality system. Most founders fail to know that you, as the head of the company, are responsible for the quality pathway of the product. Therefore, it is crucial for you to know and understand the quality landscape right from the beginning. Why is this so important? The FDA and quality management systems are separate yet integrated. The FDA has specific quality requirements that, if not followed, will cause your FDA submittal to be dismissed. Failing to meet these requirements can result in setbacks of significant time and significant financial costs.

So, what exactly is a quality management system (QMS)? It is documentation that maps out processes, procedures, and policies to ensure that the company consistently meets required quality standards. It provides a structured framework for managing quality throughout the company’s operations, from research and development to manufacturing and distribution. QMS is imperative to maintain the satisfaction and safety of patients and clients.

One important component of QMS is the Design History File (DHF). It serves as comprehensive documentation of the design and how it was developed. DHF includes records, data, and information related to the design, manufacturing, and testing of the device from the beginning through the development lifecycle.

This document helps facilitate collaboration, knowledge sharing, and strong communication with team members. It will also enable a smoother transfer to manufacturing or future development. It also helps mitigate and manage safety, efficacy, and product quality risks.

Founders, we want to ensure you understand the quality path to avoid delays and FDA rejections. We invite you to join the Quality for Founders. The course will help you understand the quality management system, what you need to get started, and how to grow your QMS. It also provides a checklist of what QMS systems you need in place and when.

This 6-week virtual course starts on September 14, 2023, and offers a combination of cohort learning and one-on-one coaching to address your specific company. Additionally, you will gain access to valuable templates and other resources that will support the development of your quality systems.

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