Casey Medina, CSEP 2

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1 Casey Medina, CSEP

2 Casey Medina, CSEP 2

3 Proving Safety and Performance Casey Medina, CSEP 3

4 Preclinical studies are in vivo or in vitro studies used to determine the safety and performance of a test article. (Your medical device) Preclinical studies are necessary when the data will be submitted as evidence of safety or achievement of marketing claims. Preclinical studies require GLP controls. Casey Medina, CSEP 4

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6 Development work supports a plan that describes the strategy for testing and evaluation. Requirements are complete and well-written. Risk analyses have been performed and mitigations have been captured as requirements. The design is well-documented. Casey Medina, CSEP 6

7 Verification has been completed to show that the design meets its requirements. The design is characterized and well-understood. The study protocol has been reviewed and approved. The appropriate controls are in place according to 21 CFR 58. The prototype under test is production equivalent with respect to the requirements tested in the preclinical study. Casey Medina, CSEP 7

8 Source: Defense Acquisition University, 1993 Casey Medina, CSEP 8

9 Development Done Right Casey Medina, CSEP 9

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11 What do my stakeholders need? How can I be sure I build what my stakeholders need? What functions does the system need to perform? What are its essential characteristics? What is the system s structure? What is the function of each structural element? How will the structural elements interact? How do the Product Requirements translate to each system component? What is the plan for making sure the system s components all fit and work together? How will each domain contribute to the system s success? Casey Medina, CSEP 11

12 What do my stakeholders need? How can I be sure I build what my stakeholders need? What functions does the system need to perform? What are its essential characteristics? What is the system s structure? What is the function of each structural element? How will the structural elements interact? How do the Product Requirements translate to each system component? What is the plan for making sure the system s components all fit and work together? How will each domain contribute to the system s success? What is the solution? Casey Medina, CSEP 12

13 What do my stakeholders need? How does the market respond to my design? How can I be sure I build what my stakeholders need? Did I satisfy the User Needs? What functions does the system need to perform? What are its essential characteristics? Did I satisfy my system requirements? What is the system s structure? What is the function of each structural element? How will the structural elements interact? How do the subsystems fit and work together? How do the Product Requirements translate to each system component? Did I satisfy my subsystem requirements? What is the plan for making sure the system s components all fit and work together? How do the pieces fit together? How will each domain contribute to the system s success? Did I satisfy my domain requirements? What is the solution? Casey Medina, CSEP 13

14 What do my stakeholders need? How does the market respond to my design? How can I be sure I build what my stakeholders need? Did I satisfy the User Needs? What functions does the system need to perform? What are its essential characteristics? Did I satisfy my system requirements? What is the system s structure? What is the function of each structural element? How will the structural elements interact? How do the subsystems fit and work together? How do the Product Requirements translate to each system component? Did I satisfy my subsystem requirements? What is the plan for making sure the system s components all fit and work together? How do the pieces fit together? How will each domain contribute to the system s success? Did I satisfy my domain requirements? What is the solution? Casey Medina, CSEP 14

15 What do my stakeholders need? How does the market respond to my design? How can I be sure I build what my stakeholders need? Did I satisfy the User Needs? What functions does the system need to perform? What are its essential characteristics? Did I build the RIGHT THING? Did I build the THING RIGHT? Did I satisfy my system requirements? What is the system s structure? What is the function of each structural element? How will the structural elements interact? How do the subsystems fit and work together? How do the Product Requirements translate to each system component? Did I satisfy my subsystem requirements? What is the plan for making sure the system s components all fit and work together? How do the pieces fit together? How will each domain contribute to the system s success? Did I satisfy my domain requirements? What is the solution? Casey Medina, CSEP 15

16 Verification answers the question: Did I build the THING RIGHT? Validation answers the question: Did I build the RIGHT THING? Verification proves, through objective evidence, that the design satisfies its requirements Validation proves, through objective evidence, that the design satisfies its intended use. Casey Medina, CSEP 16

17 Maximizing Your Resources Casey Medina, CSEP 17

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19 The regulations are complex with complex interpretations often specific to a particular class or type of device. Effective requirements engineering at the start of the project ensures your device and your team is ready for preclinical studies. Proper characterization of your designs during development and verification will ensure there are no surprises during preclinical studies. Casey Medina, CSEP 19

20 Always have a regulatory specialist available that understands your product s regulatory environment. If you can t afford to have one on your staff, put a contractor on retainer. Always make sure you are asking the right questions. It becomes very expensive to change your device late in the development process. A good systems engineer on your team will save money and time. Make sure your quality processes (QMS) enable preclinical development without adding unnecessary administrative overhead. Casey Medina, CSEP 20

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