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What the FDA's new MDDS guidance means for you

Medical Device Data Systems (MDDS) are hardware or software products intended to transfer, store, convert the format of, or display medical device data. … See more

Actived: 2 days ago

URL: https://www.qualio.com/blog/fda-mdds-guidance-update

What is cGMP in the pharma industry

WEBThe premise of cGMP is that the quality system is based on the principles of Quality by Design instead of Quality by Inspection. If you’ve been in the pharmaceutical industry for …

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25 impressive medical device startups to watch in 2024

WEBOur list of the top 25 best medical device companies in 2024. 1. LegWorks. LegWorks is a medical device company providing quality prosthetic knees and making …

Category: Medical Go Health

The 3 FDA medical device classes: differences and examples

WEBAny medical device approved by the FDA Center for Devices and Radiological Health is classified into one of three classes: either Class I, II or III, …

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Software as a medical device: Definition, examples, and

WEBThe International Medical Device Regulators Forum (IMDRF), which consists of medical device regulators from around the world including the FDA, defines SaMD as …

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What's the difference between a Class I and Class II medical

WEBFDA Medical Device Classifications. Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate …

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What are the 6 Essentials of a Clinical Evaluation Report (CER) for

WEBStage 0: Scope and plan. Identify the scope of the medical device and the CER report and create a plan for the clinical evaluation. Stage 1: Identification of …

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What is ISO 15189

WEBISO 15189 is the international standard that outlines the quality management system and competence requirements that apply to medical laboratories. The most …

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PMA meaning: understanding FDA pre-market approval

WEBThe FDA PMA process is a US regulatory pathway for the approval of high-risk medical devices before they can be marketed and sold. The PMA process is …

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5 Staggering Medical Device Recall Statistics That Should

WEB1. Recalls Jumped 71% in 2018 and 2019 vs. the Previous Two Years. 409.5 million medical device units were recalled in 2016-2017, averaging 58.19 million …

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From Hippie to Med School to Entrepreneur with Dr. Hana, MD

WEBDr. Hana Solomon, MD graduated from the University of Missouri Columbia School of Medicine in 1986 and completed the university's pediatric residency program …

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9 Ways Canadian Medical Device Regulations Differ From the US

WEBThe Canadian approach to medical device regulation has many similarities to FDA requirements in the US and even more differences. US-based medical device …

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Complete guide to computer system validation in 2024

WEBThe Second Edition of the ISPE’s GAMP 5 computer system validation guidance was released in July 2022, replacing the First Edition unveiled in 2008. The …

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Top pharmaceutical companies: 5 start-ups to watch in 2024

WEB3. Roivant Sciences. Third on our list of top pharmaceutical companies to keep an eye on in 2024 is Roivant Sciences. Roivant Sciences develops transformative …

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The 9 top medical device consulting firms you should consider

WEBThe 9 top medical device consulting firms in 2024. QES Medical. Rook Quality Systems. MWA Consulting. Cannon Quality Systems. Effectum Medical. Medpoint. Red …

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ICH Q9 quality risk management: an introduction

WEBICH Q9 introduces the technique of pharmaceutical quality risk management as a standardized tool that: Improves decision-making and identification of patient …

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Qualio — The leading eQMS for quality-focused companies

WEBA complete electronic quality management system. Connect your business with an all-in-one digital eQMS that grows with you. Build and execute standardized workflows for …

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5 secrets to securing medical device venture capital in 2023

WEBAn electronic quality management system (eQMS) platform like Qualio is designed to grow with your team, giving you a flexible long-term quality approach to …

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6 strategies for successful biotech funding

WEBThe biotech industry is booming. After a slight dip in the days of COVID, funding in biotech has ultimately skyrocketed. A McKinsey article found U.S. and …

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