How to Build a QMS for a Medical Device

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures. In this episode of the Global Medical Device Podcast, Jon Speer talks to quality and regulatory expert Mike Drues, president of Vascular Sciences. Together they discuss why a QMS is so important to a company as it sets up its business and processes. Laying a proper foundation for a QMS to operate at its full capacity is just as critical, which involves a shared mindset and philosophy across the organization that reinforces a culture of True Quality. Some highlights of this episode include: • A QMS is not a system of compliance. It should describe how business is conducted through policies, procedures, processes, and philosophies. • If a QMS consists of devices not manufactured by the company, it’s an example of the copy-and-past approach to be compliant, but not customized. • A QMS is important to describe, document, and demonstrate roles, responsibilities, and rules to make decisions about products for patients. • A QMS focuses on four key areas: Accountability, traceability, consistency, and continuity. • Preamble/Introduction: One company’s QMS should not be a carbon copy of another company’s QMS. It should focus on its own mindset and philosophy. • Every QMS should include complaints, change management, and customer feedback to trigger notifications that affect safety, efficacy, and performance. • Product Lifecycle: During research and development, conduct post-market surveillance, beta test change management, and review risk management plan. • Document Management Control: All complaints and conflicts are not created equal. Get it right to make sure it’s effective and efficient.