Regulatory Basics

Priory Analysts' uses a ‘5x5' matrix in approaching regulatory affairs.  ‘five-by-five' means Five Rules and Five Steps.

Five Rules in Regulatory:

Rule 1: In the medical device business regulatory is king - but must not be dictator

Rule 2: Regulatory requirements must be considered from design concept to disposal

Rule 3: What trading blocks or markets are we aiming at?

Rule 4: Record everything

Rule 5: The source of good regulatory is good, ethical science. However not all good science is good regulatory

Five Steps in Regulatory:

Step 1: Define the product - what does it do? Is it a medical device?

Step 2: Know the law

Step 3: Plan the data requirements

Step 4: Write everything down clearly, concisely and well structured

Step 5: Undergo assessment by an external regulatory authority