Resources, including White papers, Case Studies and Events

The Cognition Design Controls Template runs on Cognition’s powerful Cockpit Platform. Using this template, teams are guided through the process of Design Controls as defined by FDA in 21 CFR 820.30.

Download the white paper “Cognition’s Guided Approach: Design Controls Template” to see how this template can help you!

• Created with small to medium sized businesses in mind
• Guided approach designed to assist with compliance of 21 CFR 820.30
• Easily modifiable to suit your team’s needs
• Templated approach allows for re-use with multiple programs
• End up with deliverables suited for regulatory submissions

Applying the right strategy to navigating the regulatory landscape, improving product usability, introducing human factors as well as integrating digital platforms for product design is the next step to developing combination products that will lead the industry.

• Understanding how to make sense of the regulatory contradictions with exclusive case studies on different strategies for navigating regulatory pathways
• Debating how to prioritise different regulations when producing novel combination products with panel discussions, workshops, and round tables designed to generate novel solutions
• Analysing how device and drug approaches could harmonise with one another to improve mechanisms and product usability of combination products
• Discussing the E-health wave and digitalisation of technology, and how they are going to impact future designs of combination products