Regulatory Articles

1. Considerations In Combination Product Risk Management 11/30/2020

   Drug-device combination products are rapidly increasing in use based upon the numerous benefits they provide. Successful development and commercialization requires demonstration of performance and regulatory compliance. This article is a brief review of a webinar that discussed approaches to achieving both.

2. Demystifying Performance Testing: Strategies To Qualify Combination Products 11/30/2020

   Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.

3. Connecting The Dots Between Quality, Engineering, And Regulatory To Increase Innovation And Improve Operational Efficiency 10/14/2020

   This article presents a Single Source of Truth (SSOT) solution for all medical device-related information so that all stakeholders have access to relevant information at any time. By controlling information and making it accessible across an organization, teams can focus on quality, accelerate innovation, and improve operational efficiency while ensuring global regulatory compliance.

4. 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.

5. Test Method Development, 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.

6. The Criticality Of Process Validation 10/28/2019

   Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.

7. 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.

8. Clearing The Hurdles Of Medical Device Prototyping 5/30/2019

   Material costs, functionality, and turnaround times are major obstacles in medical device prototyping. This article presents tools and techniques to overcome them and explains how the right partner can ensure medical devices are brought to market quickly.

9. 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. 

10. 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.