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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systems engineering | Medical Device | Product Development

Accelerate Medical Device Product Development with Systems Engineering

By: David M. Cronin
October 16th, 2020

Systems engineering should be used more often in medical device product development. This may be a strong statement, but it can be transformative for device development through decreased development costs, streamlining of interactions with the FDA, and reduced time-to-market. We would like to address this through a series of articles on systems engineering role in Medical Device Product Development of which this is the first.

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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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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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Product Development | Thought Leadership | Research & Development | Risk Management | Usability

How Engaging Patients Benefits Life Science Product Development

By: Cognition Corporation
November 19th, 2019

Your product’s intended patients have a wealth of experience and information that can be valuable to your development process. Whether it’s the day-to-day realities of the condition, the symptoms they feel need the most attention, or things they might be missing in their current treatment regimens, this data cannot be elicited from doctors and engineers alone.

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Product Development | Thought Leadership

9 Methods for Improving Your Life Science Product Development Processes

By: Cognition Corporation
May 23rd, 2019

Life science product development is all about process: to ensure safety and effectiveness of your product, processes must be in place to maintain high quality in your design and development work. In smaller organizations, these processes and procedures can be fairly easy to control and manage. However, as your business grows, so do the scope and complexity of your development activities. To maintain and improve your life science product development processes, there are a handful of methods your organization can undertake.

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