Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Ep 18: Risk based approach to building a QMS in a startup
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Ep 18: Risk based approach to building a QMS in a startup

Insights from a Let's Talk Risk! conversation with Becki Hiebert

In this episode, Becki Hiebert recommends taking a strategic approach to building and implementing a Quality Management System (QMS) in a startup.

Unlike a mature, established organization, a startup operates in a fast-paced and rapidly changing environment. That is why you have to think about both speed to support the near term goals, and scalability to support rapid growth in the future.

Her advice - focus on building the right mindset about Quality, use a risk-based approach to create a flexible system and nurture a collaborative work culture.

About Becki Hiebert

Becki Hiebert is currently the QA/RA lead at PulseMedica in Canada, where she is helping the development and commercialization of 3D imaging and laser targeting systems for precise retinal surgery. In her 10+ years of professional experience across both pharmaceutical and medical device industries, she has developed a hands-on expertise in regulatory requirements for current good manufacturing practices. She has served in a variety of roles in quality planning, process improvement, internal audits, quality system training and supplier/purchasing programs.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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Discussion about this podcast

Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!