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Software as a Medical Device (SaMD)

Software as a medical device or SaMD is “software intended for one or more medical purposes that perform those purposes without being part of a hardware medical device,” as defined by the International … See more

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CAPA: Guide to Corrective and Preventive Action for …

WebAs noted throughout this guide, CAPA is an important process for your medical device company. In fact FDA states in their QSIT guide: “One of the most …

Category: Medical Go Health

The Ultimate Guide To Design Controls For Medical …

WebIt is an expected best practice that you integrate Design Controls and Risk Management during your medical device product development efforts. For Risk Management, be sure …

Category: Medical Go Health

Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)

WebQMS Tool #5: CAPA Management. CAPA, CAPA, CAPA. The number one reason for FDA 483s for as long as any of us can remember. Getting your CAPA …

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Definitive Guide to Change Management for Medical …

WebThis is very important because of the impact to timeline for changes. In the United States, devices may require a 510 (k) submission, a post-market approval (PMA) supplement, or …

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Medical Device Classification Guide

WebThe FDA medical device classes are based primarily on the risk the device poses. Class I medical devices are generally deemed low risk. Class II medical devices …

Category: Medical Go Health

eIFU Requirements: Essential Guide to Electronic Instructions for Use

WebIn the EU, the requirements for information to be provided with the device, which covers eIFU, can be found in Annex 1, Chapter III of EU MDR: Instructions for use …

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What is Software as a Medical Device (SaMD)

WebSoftware that allows MRI and other types of medical imaging to be viewed on regular mobile devices. Software that performs image processing in to detect cancer. …

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Electronic Data Capture (EDC) Systems: Everything You Need to …

WebAn Electronic Data Capture (EDC) system for clinical trials or studies is a software solution that makes it easier for medical device companies to digitally collect, store, and manage …

Category: Medical Go Health

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

WebThe date of ratification (DOR) by CEN was July 4, 2021, for the EN ISO 15223-1 version of the standard and it is considered equivalent to the ISO 15223-1 other …

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Top 20 Medical Device Venture Capital Firms

WebPortfolio Highlights: Acclarent, Earlnes, CVRx. New Enterprise Associates is a full service venture capital firm that makes investments ranging from $50,000 to $20 …

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ISO Standards for Medical Devices: Ultimate List & Overview

WebThe International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for …

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ISO 14971 Risk Management for Medical Devices: The Definitive …

WebRisk per ISO 14971 is defined as the combination of the probability of occurrence of harm and the severity of that harm. The intent behind Risk Management is to identify, …

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Top Medical Device Conferences To Attend in 2024

WebThe 42nd Annual Healthcare Conference will take place on January 8-11, 2024 in San Francisco, CA. This premier conference is the largest and most informative …

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Ultimate List of Medical Device Incubators and Accelerators (50+)

WebIn their annual 2016 report, the incubator boasted a total of $5.2M invested in 27 different companies, with an average salary of $86K across all startups funded by the …

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Top 100 Medical Device Companies (Free Chart Included)

WebDraegerwerk AG & CO KGAA is a German medical device company that makes breathing and protection equipment as well as systems for gas detection, analysis …

Category: Medical Go Health

Top 50 Medical Device Product Design and Development Companies

WebSterling medical devices is a product design and engineering firm that focuses exclusively on the medical devices market and has contributed to the …

Category: Medical Go Health

3 Pros and Cons to 3D Printing for Medical Devices

Web3 Pros of 3D Printing Medical Devices. 1. Personalized Medical Devices and Patient-Specific Implants. 3D printing can create medical devices and implants that are …

Category: Medical Go Health

Top 40+ Medical Device Contract Research Organizations (CROs)

WebArcher Research. Website: archerresearch.eu. Location: Diepenbeek, Belgium. Archer Research is a full-service Contract Research Organization specializing …

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