As one of the most regulated spaces for innovation, medical device companies need to focus on compliance and quality. Medical device companies should have a QMS in place before they make their first sale. But how do you build a QMS that works and how do you engrain quality into your company from day one?

Join us for part 1 of a 3 part series with Mach7 technologies Director of Process and Quality, Christie Eby as she shares a roadmap to help you build a QMS and foster a quality based culture - from startup to scale.

In this session, Christie will review the basics of QMS and help early stage companies get started building a QMS from scratch and help growing and scaling companies improve on existing processes.

About Christie Eby:

Christie Eby brings over 20 years of experience in the health IT field, in the areas of: Medical Device Regulatory, Quality Systems, Change Management, Process Improvement, Facilitation, Software Development and HR. For the last 10 years she has been part of a management team at a start-up graduate from the AC: Client Outlook Inc. (recently purchased by Mach7 Technologies in July 2020)

Client Outlook’s flagship product is eUnity, a medical image viewer. At Client Outlook Christie took on many roles and focused on processes, operations, and QMS to ensure global standards were met or exceeded. Christie was instrumental in leading Client Outlook to QMS to certification/compliance in: ISO 13485:2016, MDSAP, CE Mark, TGA, ISO 62304, Health Canada, ISO 14971. In addition, she ensured compliance with regulations and standards as the Software Development team moved from Iterative Development into Agile and Scrum methodologies. Finally, Christie also took on the role of HR, and scaling up. Being one of the first ten employees, Christie was instrumental in the growth and culture to build the team up to 50 people.

Prior to Client Outlook, Christie was an Operations team member for the Global Informatics Business Unit at Agfa, and a member of the Quality Management team for international software development sites involved in Medical Devices.

Interested in more great medical device sessions. Check out these other great QMS events.

Part 2: Pragmatic Quality: Building quality into the fabric of your business

Part 3: Engaging your team in quality assurance