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Everything You Need to Know About the Medical Device Single …

WebThe goals of the single audit program are twofold: to avoid spending duplicate regulatory resources across multiple countries, and to minimize disruptions of medical device …

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URL: https://www.rqmplus.com/blog/everything-you-need-to-know-about-the-medical-device-single-audit-program-mdsap

A Quantitative Approach to Benefit-Risk Determination

WebRisks. ISO 14971 defines risks as the frequency of occurrence of a harm combined with the severity of the harm, the harm being injury or damage to the health of …

Category: Health Go Health

What Are Clinical Benefits and How Do You Evaluate Them in Your …

WebDefinition of Clinical Benefit. EU MDR Article 2-53 defines a clinical benefit as: “The positive impact of a device on the health of an individual, expressed in terms of a meaningful, …

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Wellness Devices vs. Medical Devices

WebPer a recent draft guidance document, FDA defines a wellness device or product as one that is only intended for general health and wellness and which also presents a very low risk …

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How to Submit FDA CDRH Submissions Online

WebYou first start by logging into the CCP and selecting “Send a submission”. From there, you are given the option to submit an eSTAR or an eCopy of the submission. After selecting …

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Top Ten Tips and Best Practices for PMCF Surveys Under EU MDR

Web10 November 2020 - RQM+ experts have come up with a list of our top ten suggestions for mastering Post-Market Clinical Follow-up ("PMCF") Surveys under the European Union's …

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RQM+™ Selects THREAD to Power New Medical Device Research …

WebPITTSBURGH, PA and CARY, NC, 25 JULY 2023 – RQM+, the world’s leading MedTech service provider, and THREAD, a leading decentralized research and …

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FDA CDRH 2021: A Year in Review

WebLingering effects of COVID-192. While 2021 saw the start of a return to normalcy for CDRH, the impact of COVID-19 continued to linger and has not affected all of CDRH evenly. …

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Quick Guide to Medical Device Standards: ISO Standards and …

WebISO 15223, which has two parts, is the standard for symbols to be used with medical device labels, labeling, and information to be supplied. ISO 11135, which is the standard for …

Category: Medical Go Health

RQM+ Quick Guide to Medical Device Recall Management

WebIn the U.S., a medical device recall is the voluntary correction or removal of a product that is currently on the market. A correction is defined as the “repair, modification, adjustment, …

Category: Medical Go Health

Overcoming the Most Common Periodic Safety Update Report …

WebGLOBAL BOTTOM CTA INSTRUCTIONS: To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" …

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Summary of FDA Regulatory Changes for Digital Health Devices in …

WebThe Digital Health Policy Navigator is a tool designed to help you determine the appropriate regulatory path for your digital health device. Each step directs you to …

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What You Need to Know About Significant Changes Under IVDR

WebArticle 110 section 3 of the IVDR limits significant changes to changes in design and intended purpose. MDCG 2020-3 gives clarity on what should be understood …

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Canada Regulations News for Medical Devices and IVDs

WebThe amendments to the Medical Devices Regulations that published in the Canada Gazette, Part II (CGII) in 2020 are: the preparation, retention, and submission of summary reports …

Category: Medical Go Health

Preparing for the Phase-Out of PFAS in MedTech Manufacturing

WebHere are five key steps for phasing PFAS out of your products: Perform a PFAS Gap Assessment — the first step involves a comprehensive assessment of existing product …

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Latex and DEHP and BPA, Oh my!

WebBispheonol A (BPA) is a chemical that is used to manufacturer polymers, mainly polycarbonate polymers and epoxy-based enamels and coatings. Since polymeric …

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