Medical Device Design Inputs

Medical device design and development is a complex process rife with regulations specifications application requirements and end user needs all of which must be balanced and adhered to for a successful product.

Medical device design inputs.

Properly identifying what the design inputs should be and specifying them in such a way that they can be objectively. Design inputs are the king of medical device product development. Medical device cfr 820 design inputs this standard operating procedure sop describes the design input which is part of the design control process by which the activities associated with the planning design and development of a new medical device are controlled and documented. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use.

Design inputs are the foundation of a medical device and your device is only as effective as the inputs used to create it. Design inputs are the foundation of medical device development. If your device lacks usability market share will suffer but if your device doesn t meet regulatory guidelines it won t make it to the ultimate guide to medical device. Design control is not just about controlling the design inputs.

It is also essential to know whether those design and development inputs result in the right outputs namely whether the design you created is safe and functions as planned. If you are developing a class ii medical device for a 510 k submission to the fda special controls guidance documents will include design inputs. Medical device design outputs. After defining user needs understanding how to develop and document design inputs and outputs is the critical quality task in medical device design and development.

Design inputs are typically the device requirements both physical and performance describing the medical device you re going to make. If you are developing a class iia class iib or class iii medical device for ce marking there is probably an iso standard that lists functional performance and safety requirements for the device. Medical device design inputs and outputs are your friend. Design inputs provide the important criteria that must be included in the design of the actual medical device.

Section 820 30 c of the fda guidance says. Call them what you want design inputs design requirements design and development inputs etc getting your design inputs right is the most important thing you can do to make sure your device.