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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requirements | design controls | Design Inputs | 21 CFR 820.30 | user needs

The Importance of Linking User Needs with Design Requirements

By: Sally Carter
October 1st, 2020

There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and external customer requirements, to name a few. Finding harmony and documenting everything is not a simple paperwork exercise. This can be overwhelming to even the most seasoned medical device professional. How do you make sure the user needs are linked to actionable requirements, and ensure that all requirements have been addressed?

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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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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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Medical Device | Risk | Risk Management | ISO | FMEA

Complying with ISO 14971:2019

By: Ben Higgitt
August 11th, 2020

SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.

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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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Thought Leadership

How Adopting Compliance Software Tools Promotes Long-Term Growth

By: Cognition Corporation
November 27th, 2019

There are many immediate short-term benefits a compliance software tool can provide to your life science organization: improved documentation, streamlined day-to-day compliance activities, project data unification, and other advantages. But there are many important long-term benefits that may get overlooked. When deciding to adopt these software tools, it’s important to understand how they can promote growth and innovation at your company.

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Thought Leadership

3 Important Guidance Documents on Digital Health Products

By: Cognition Corporation
November 21st, 2019

The market for digital health products is rapidly expanding. Reports from Global Market Insights, Inc. project the value of this marketplace to expand to $504.4 billion by 2025. Many life science organizations have seen the opportunity these technologies can provide and are jumping at it. However, this boom in the industry has not gone unnoticed; in recent years, FDA has been rapidly transforming their policies and organization to handle the necessary regulatory work these digital health products bring to the table.

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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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Thought Leadership

3 Commonly Cited Design Controls in FDA Form 483s

By: Cognition Corporation
November 14th, 2019

FDA Form 483 Inspectional Observations are one of the many tools the agency uses to verify medical device products do not expose users and patients to undue risk. Many of the commonly cited observations involve some aspect of design controls regulations, which is of particular concern for development teams and manufacturers. Of the 438 inspectional observations in FY2017, FDA cited three design controls regulations more commonly than all others:

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