Medical Device and Pharmaceutical Product Development and Compliance

Navigating Product Development and Compliance

Helping to navigate product development and compliance for the life science industry. Our SaaS-based solutions enable customers to structure their data and automate compliance processes with built-in quality templates and automated generation of deliverables to save time and money, delivering their products to market faster with less risk.

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Medical Device | Product Development | Compass | Process

Only a Comprehensive Process Can Deliver True Quality in Medical Device Development

By: Ansgar Liening
August 27th, 2020

Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed.

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design controls | Medical Device | Compass | documentation | 483

Mitigate the Risk of Receiving an FDA Form 483 with an Automated Solution

By: Deepesh Moolchandani
July 27th, 2020

Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483 is often referred to as “Inspectional Observations” as it is a list of conditions or practices that indicate a potential violation of FDA requirements. The form is compiled in order of importance and is considered a snapshot of potential issues; it should not be considered all-encompassing.

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How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

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