Module 14 2022
14/03/2022
Design Input
The Organisation for Professionals in Regulatory Affairs
19
Design Input Sources Standards Focus Groups
Design Inputs
• Device functions • Physical characteristics • Performance • Safety • Reliability • Standards • Regulatory requirements • Human factors • Labelling & packaging • Maintenance • Sterilisation • Compatibility • Environmental limits
Intended Use Definition
Customers
MDRs
User Requirements Specification
CAPAs
Service Reports
Complaints
User Req. 1.3 “The drug shall be delivered into intramuscular tissue”
Marketing Surveys
Sales Feedback
Competitor Products
The Organisation for Professionals in Regulatory Affairs
20
10
Made with FlippingBook Annual report maker