Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

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    How To Implement Continuous Process Monitoring Of Validated Processes

    It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.

     

ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices

Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.

How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data

Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

ISO’s Updated 22442 Animal Tissue Standards — What Changed?

This article provides a high-level summary of the updates to ISO 22442-1:2020 ( Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management) and ISO 22442-2:2020 (Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling).

Ask The Expert With Christian M. Kelly – Corporate Vice President Of Quality At B. Braun Medical Inc.

This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.

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WHITE PAPERS & CASE STUDIES

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    Connecting The Dots Between Quality, Engineering, And Regulatory To Increase Innovation And Improve Operational Efficiency

    The success of medical device companies relies on their ability to produce innovative products while focusing on the need to meet strict regulatory requirements, facing the demands of competition and time-to-market pressures, as well as reducing costs as much as possible. This article presents a Single Source of Truth (SSOT) solution for all 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.

Finding The Ideal Balance – Where Risk And Cost Of Quality Meet

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. These critical processes are needed to reach and maintain the optimum operating space while providing the overall value that customers seek. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

Test Method Development, Experimental Design And Positive Controls For Package Integrity

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.

The Criticality Of Process Validation

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.

A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices

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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ABOUT MEDICAL DEVICE REGULATIONS & COMPLIANCE

Medical devices, from ideation to post-launch assessment, are regulated in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 and subsequent amendments to the Federal Food, Drug and Cosmetics Act of 1938.

The FDA’s medical device regulatory pathways — for premarket review, clearance, and approval — are based on three classifications, indicating the degree of regulatory control necessary to ensure a device’s safety and effectiveness. Class I devices are considered low-risk, and many are exempt from the regulatory process. Class II devices require special controls for “labeling, guidance, tracking, design, performance standards, and postmarket monitoring,” and most require premarket notification 510(k) to demonstrate substantial equivalence (having the same intended use and technological characteristics) to a legally marketed device. Class III devices usually sustain or support life, are implanted, or present a significant risk of illness or injury. Most class III devices require premarket approval (PMA), which examines a variety of factors in weighing the probable health benefits from intended use of a device versus the probable risks.

Medical device makers must adhere to Current Good Manufacturing Practice (CGMP) regulations, which FDA inspectors use to determine if a manufacturer has the facilities, skills, and equipment to produce and pack its product. In addition, the FDA requires all medical devices to carry a unique device identifier (UDI), readable by both machines and humans, to “improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”

Medical device makers competing in international markets must monitor and adhere to the policies of foreign regulatory bodies, which can vary greatly, depending on the nation. Further, many global regulators require manufacturers to be certified by the International Organization for Standardization (ISO). ISO 13485 compliance, confirmed through third-party (Notified Body) audits, demonstrates a medical device manufacturer’s procedures and products meet or exceed international quality standards.

Efforts are also underway to standardize international regulations to ensure the safety, effectiveness, and quality of medical devices. The International Medical Device Regulators Forum (IMDRF) — composed of regulatory agencies from Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States — is building upon previous work by the Global Harmonization Task Force on Medical Devices (GHTF) to speed this harmonization and convergence.

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