The Challenge

In 2021, the FDA issued new guidelines for the regulation of artificial intelligence and machine learning-based medical devices, reflecting the challenges of adapting regulatory frameworks to rapidly evolving technologies.

Meeting stringent regulatory requirements and obtaining approvals from regulatory agencies such as the FDA (Food and Drug Administration) in the United States and the CE Mark in Europe is a complex and time-consuming process, which presents many challenges for medical device manufacturers.

The Solution

Capsifi helps by providing a clear line of sight from relevant legislation and policies, through to the organizational controls that enforce them aligning to investment into the operating model and initiatives for change. In this way, evidence of compliance becomes incidental, alleviating what is traditionally a resource-intensive and error-prone activity. With Capsifi, regulatory frameworks become another lens through which the operating model can be assessed and the cost of implementing those compliance frameworks ascertained.

Operationally, the method of securing approvals from regulatory agencies can be modelled, analyzed and assessed to identify inefficiencies and blockers that may potentially delay getting essential medical equipment to market.

Here’s some practical ways the Capsifi platform can address and resolve these industry-wide challenges:

Establish a clear line of sight from legislation and policy to controls, business rules, and operating model elements
Establish a clear line of sight from legislation and policy to controls, initiatives, or projects, and epics (including costs)
Use Value Stream for the approval process to ensure maximum efficiency