2021 - Integrating Design Controls and the Product Development Process for Effective and Compliant Medical Device Development

An overview of existing regulatory literature as applied to design controls
A detailed walkthrough of design controls activities and deliverables required by existing regulations, standards, and guidance
The components of a Quality Management System and a Business Management System
The structure of a stage gate product development process
Mechanisms to advancing through stage gates
Application of a product development process to a serialized or v-model development approach
Application of a product development process to an iterative (e.g. Agile scrum, SAFe) development approach
Adapting the product development process to change management and post-production maintenance
Defending design controls when embedded in a product development process