Regulatory Articles
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Do I Need To Validate? How To Make An Informed Decision In 4 Steps
8/24/2021
Nobody ever said software validation is easy. Validation is twice as tough if you are plagued by uncertainty and asking yourself: do I really need to validate? It’s a legitimate question. In this paper we walk you through the necessary thought process to make an informed decision.
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What Is The True Cost Of Not Having An eQMS?
8/23/2021
It is safe to assume that no organization that intends to stay in business sets out to manufacture or provide a low-quality product. This is particularly true for highly regulated companies. And yet switching from a manual quality management system (QMS) to an electronic one in order to improve product quality and ensure regulatory compliance remains low in most companies’ list of priorities. In this white paper we discuss the most common “quality pains” I’ve seen among regulated companies and offer some strategies on choosing and executing an eQMS.
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9 Pitfalls To Avoid During The Document Control Process
8/23/2021
In order for the document control process to be a smooth ride to a successful product launch, you need effective control in every phase of the life cycle of every important document. In this white paper, we discuss common issues in every phase of the life cycle of a document.
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The New Digital Pathway For Regulatory
8/23/2021
As medical devices become more complex – mixing both device and drug delivery and/or integrating software, applications or connected sensors – the regulatory environment is becoming more challenging. Companies must strategically invest in a strong interoperable digital infrastructure, and harness data to expand their business models and position themselves to compete in a transformed environment.
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Change Control – Continuous Quality Improvement In FDA And ISO Environments
8/23/2021
The fact that change is inevitable makes control a critical factor, especially in FDA and ISO-environments, where inappropriate or “uncontrolled” changes could affect the safety and reliability of products and directly impact public health and safety. This paper explains the definition of change, regulatory requirements, as well as the elements and challenges of change control.
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Finding The Ideal Balance — Where Risk And Cost Of Quality Meet
10/6/2020
It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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Experimental Design And Positive Controls For Package Integrity
4/9/2020
Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.
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A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices
7/9/2019
It has been reported that 83,000 deaths and 1.7 million injuries have been linked to medical devices adverse events over the past decade. There is indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations, possibly leading to medical devices that pass FDA HFE validation yet still exhibit significant use errors when utilized in the real world. This paper explores the possible sources of HFE performance problems with medical devices and links potential problems to HFE validation methodologies within the FDA HFE guidance framework.
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Preparing For MDR? Start With A Gap Analysis
5/14/2019
With the EU MDR going into effect in about a year, medical device manufacturers are gearing up to prepare product lines for the massive regulatory changes. The planning and pre-clinical testing necessary for MDR compliance can be an exhaustive, multi-faceted venture.
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Single-Touch Labeling: The Answer To EU MDR?
4/29/2019
Warren Stacey, PRISYM ID, examines a single-source approach that could eradicate data duplication, inconsistencies, and costly human error.