Medical device regulations require information to be recorded as you develop; this includes how the design was created, why design decisions were made, and what risks were considered in the process. Here is a basic outline to get you started.
Read MoreA strategic tool for any business, ISO standards can reduce costs, satisfy consumers, open access to new markets and improve product performance. Read about the benefits of developing your product under ISO 13485 standards.
Read MoreMaren Nelson, a PMP-certified, medical device consultant for Product Creation Studio talks to startups on how they can establish informal documentation from the start, examples of accepted criteria and three guiding principles of any quality management system.
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