Regulatory Articles

1. 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.

2. 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.

3. 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.

4. 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. 

5. 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.

6. Keeping Up With Counterfeiters: The Battle Against Counterfeit Medical Devices 4/29/2019

   Steve Ellison, PRISYM ID, examines the battle against counterfeit medical devices.

7. EU MDR Does Not Draw Distinctions 4/29/2019

   Mark Cusworth, VP of Research and Development at PRISYM ID, examines The ten steps to labeling implementation for both SMEs and large enterprises.

8. EU MDR: Are Your Labels Compliant? 4/29/2019

   Mark Cusworth, VP of Research and Development at PRISYM ID examines the EU Medical Device Regulation and its implications on labeling, and looks ahead to the future and the predicament companies will begin to face unless they start to make changes now.

9. Improving Global Labeling Workflow 4/29/2019

   One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.

10. EU Medical Device Regulation (MDR): The Useful Guide To Labeling Compliance 4/24/2019

    Compared to the previous European Regulation MDD, the new EU MDR/EU IVDR offer a change from the pre-approval stage to a life-cycle approach. One of the new aspects of the legislation is the introduction of Unique Device Identifiers (UDI) to products, allowing the ability to trace a device from its manufacturer through the supply chain to the final end user. Whether producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the new EU MDR/EU IVDR. This article offers useful guidelines for adhering to the new EU MDR/EU IVDR.