FDA

FDA Announces Funding Opportunities for Medical Device Development Tools

By MedTech Intelligence Staff

The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…

The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…

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Mohamed Benkirane
MEDdesign

Raising the Bar on Quality for MedTech Production

By Mohamed Benkirane

…speeding up new product introductions and complying with increased regulatory requirements. Benefits of Predictive Quality Predictive quality is a proactive and adaptive approach to build quality into processes. It combines…

…speeding up new product introductions and complying with increased regulatory requirements. Benefits of Predictive Quality Predictive quality is a proactive and adaptive approach to build quality into processes. It combines…

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Veranex logo

Veranex Acquires Medidee

By MedTech Intelligence Staff

…The combined companies will offer a full spectrum of integrated concept-to-commercialization services, including design, engineering, regulatory, quality, preclinical research, clinical development, clinical operations, commercial strategy and market access services.  …

…The combined companies will offer a full spectrum of integrated concept-to-commercialization services, including design, engineering, regulatory, quality, preclinical research, clinical development, clinical operations, commercial strategy and market access services.  …

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MedExecWomen Panel on M&A

M&As: Maximizing the Partnership Process on Both Sides

By Leslie Storms, Kristine Ilaria, Martha Shadan

…experienced a particular strategy and mixture of tactics that accomplish M&A compatibility that is based on strong relationship fundamentals: trust, communication and “a match.” Both larger and smaller companies may…

…experienced a particular strategy and mixture of tactics that accomplish M&A compatibility that is based on strong relationship fundamentals: trust, communication and “a match.” Both larger and smaller companies may…

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Mike Noshay

The Perils of Biased Data

By Mike Noshay

…study published in Science magazine, researchers found that “Health systems rely on commercial prediction algorithms to identify and help patients with complex health needs. We show that a widely used…

…study published in Science magazine, researchers found that “Health systems rely on commercial prediction algorithms to identify and help patients with complex health needs. We show that a widely used…

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FDA

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR (Part 820)….

testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR (Part 820)….

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Emily Newton, Revolutionized Magazine
Soapbox

Prognosis: Medical Device Security Needs Improvement

By Emily Newton

…to changing security landscapes. The HIPAA Security Rule came into effect in 2003, with its latest update coming in 2013. Cybersecurity concerns and needs have changed dramatically since then, so…

…to changing security landscapes. The HIPAA Security Rule came into effect in 2003, with its latest update coming in 2013. Cybersecurity concerns and needs have changed dramatically since then, so…

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Whitehouse 2021

Pres. Biden Issues Executive Order on Advancing Biotechnology and Biomanufacturing

By MedTech Intelligence Staff

…the bioeconomy, including by supporting a diverse workforce and ensuring the benefits of these initiatives are distributed across the country. Expanding training and education opportunities in community colleges, Historically Black…

…the bioeconomy, including by supporting a diverse workforce and ensuring the benefits of these initiatives are distributed across the country. Expanding training and education opportunities in community colleges, Historically Black…

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Steve Severaid

Disaster Proofing Your Business

By Steve Severaid

…continuing to produce essential products. There are several options for manufacturers to continue business operations after an incident. For example, a company could partner with a competitor to share use…

…continuing to produce essential products. There are several options for manufacturers to continue business operations after an incident. For example, a company could partner with a competitor to share use…

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CVS Health

CVS Moves Toward Home Health Care with Signify Acquisition

By MedTech Intelligence Staff

CVS Health is expanding into the home healthcare business. The company announced that it has entered into a definitive agreement to acquire Signify Health, which boasts a network of more…

CVS Health is expanding into the home healthcare business. The company announced that it has entered into a definitive agreement to acquire Signify Health, which boasts a network of more…

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