Introduction
Does your company properly manage Design Outputs? The FDA routinely examines this area as part of an audit process. In this article we review what it means to have your design outputs in order as well as present some recent warning letter examples.
We invite you to download our paper on this topic.
Learn more about IT FDA requirements and compliance training best practices to help your business gain the competitive market advantage.
Are you interested in different types of SBOMs, but not sure which is right for you? Dive into this eBook to explore six different kinds of SBOMs and when to use them. What You Will Learn In this eBook, you will explore: Six kinds of SBOMs Which SBOM is best for you...
Innovation-driven industries require fast-moving, collaborative product development cycles to stay competitive. From aerospace to medical device production, uncompromising compliance is the goal. Disconnected systems, siloed data, and manual workflows can’t keep up...
Medical device manufacturers know how rapidly technologies can change in the field. Ensuring you provide hospitals with innovative tools that meet regulatory requirements is vital. When a leading medical device manufacturer needed help upgrading software and hardware...
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.Is your product lifecycle management system driving real business value—or just managing data? In this practical and engaging webinar,...