Medical Device and Pharmaceutical Product Development and Compliance

How a risk-based design approach provides safer and ultimately better quality products to market. Product designs are stronger when risk is inherently considered. Not everyone has the experience and instincts to naturally consider the critical factors required in a comprehensive approach. A solid process ensures risk is addressed consistently throughout product development by all of the stakeholders. It is not enough to intuitively consider risk when designing a product; decisions need to be articulated and documented - this documentation is used to support the design choices throughout the product's life.

Imagine developing a medical device or drug that could be claimed to work without any evidence….

There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and external customer requirements, to name a few. Finding harmony and documenting everything is not a simple paperwork exercise. This can be overwhelming to even the most seasoned medical device professional. How do you make sure the user needs are linked to actionable requirements, and ensure that all requirements have been addressed?