Regulatory Articles

31. 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.

32. 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.

33. 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.

34. 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.

35. 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. 

36. 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.

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

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

38. 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.

39. 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.

40. 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.