Bioburden testing quantifies living microorganisms on medical devices pre-sterilization, while sterility testing confirms their absence post-sterilization. Both are vital for patient safety and product efficacy.
The updated ISO 18562 standards, released in March 2024, now cover medical respiratory PPE like surgical masks and introduce new terms that could change testing requirements for medical devices. They emphasize the importance of considering a device’s aging and life cycle, as well as providing detailed breathing volumes for expanded patient populations. These changes aim to enhance safety evaluations for devices throughout their use, presenting manufacturers with new challenges.
When it comes to medical device development, regulatory compliance is essential. In the United States, the Food and Drug Administration (FDA) is responsible for regulating medical devices and, specifically, their Accreditation Scheme for Conformity Assessment (ASCA Program) provides accreditation to laboratories that assess medical devices for compliance with regulatory requirements.
This blog delves into the changes to ISO 10993-17, released in 2023. Included are several major additions to the toxicological risk assessment process.
The Mechanical Hemolysis Assay is an in vitro test used to assess the potential for red blood cell damage by comparing the hemolytic effects of test articles with a reference device to determine their compatibility with blood contact.
The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.
The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.
When it comes to medical device development, regulatory compliance is essential. In the United States, the Food and Drug Administration (FDA) is responsible for regulating medical devices and, specifically, their Accreditation Scheme for Conformity Assessment (ASCA Program) provides accreditation to laboratories that assess medical devices for compliance with regulatory requirements.
On February 17, 2022, the American Chemical Society released a publication on behalf of the U.S. Food and Drug Administration (FDA) describing the current state and opinion of the FDA regarding chemical characterization processes and ways in which to improve them. In particular, the FDA’s response is intended to examine specific topics to promote continuous discussion regarding the disparities between where the industry currently stands and how alignment and proper development may occur.
Histology is a critical step for any preclinical study when bringing a medical device to market and should not be overlooked when considering development timelines. Tissue histology provides U.S. FDA regulators with physical evidence, down to the cellular level, regarding how a device interacts with tissue
Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA.
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 18 that it is now offering an electronic Biocompatibility Assessment Resource Center intended to provide guidance for addressing and evaluating the biocompatibility of medical devices.
As discussed in NAMSA’s December 19 blog post, “The Evolution of the Accreditation Scheme for Conformity Assessment,” ASCA is an assessment created by the U.S. Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).
On October 15, 2020, the U.S. Federal Food and Drug Administration (FDA) released a new draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin,” which is intended to add or supersede applicable sections of the 2016 biocompatibility guidance (recently updated in 2020), “Biological Evaluation of Medical Devices-Part 1: Evaluation and … Continued
Tuesday, October 8, 2019–FRANKFURT, Germany–(BUSINESS WIRE)–NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research, and reimbursement and regulatory consulting services, is pleased to announce that it has been awarded DIN EN ISO/IEC 17025:2018 accreditation by DAkkS. DAkkS, the sole national accreditation body for the Federal Republic … Continued
August 28, 2018 – TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services is pleased to announce the launch of its new online development application, the NAMSA Biocompatibility Strategy Navigator. This first-of-a-kind web-based resource assists device manufacturers to … Continued
The world’s only Medical Research Organization brings 50 years of testing leadership to Germany with new Analytical Services Laboratory. FRANKFURT, GERMANY – February 1, 2018 – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research and regulatory consulting services, is pleased to announce the launch of … Continued
Medical device manufacturers producing devices that involve patient contact are required to perform biological safety evaluations, which may include the need for biocompatibility tests to ensure patient safety, as specified by ISO 10993. On June 16, 2016, the U.S. Food & Drug Administration (FDA) expanded and clarified how manufacturers should comply with the ISO 10993-1 … Continued
TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services is pleased to announce its newly-released online test selection tool, NAMSA Test Navigator, to fully support global medical device manufacturers’ testing requirements. The Test Navigator was built to provide … Continued