These Are the Contents of a Proper Product Requirements Document

Technically, the purpose of the FDA-required product requirements document (PRD) is twofold:

• To define the standards the end product must meet to satisfy your company’s internal and external customers.
• To clearly communicate what the product is, who it’s for, and how it will work and perform for end users.

But the PRD is more than a regulatory box to check. It’s fundamental to the design and development team’s ability to successfully and efficiently bring your medical product to market while meeting user needs and performance criteria.  

What’s more, the PRD touches every facet of the medical device design and development journey. It’s preceded by important documents, such as your use specification and market requirements document (MRD). 

The PRD is a functional resource and a planning resource. When done right, the PRD can streamline your entire development process — saving you time and money. 

The key phrase? When done right. 

In practice, getting the PRD right can be difficult because the FDA does not offer a template to do so. 

That’s where this resource comes in. It’s a partially completed PRD. It starts with the table of contents so you can see exactly what goes into a quality doc. Gain an understanding of what you need for your own PRD now.