Medical Innovation Exchange

Quality/Regulatory

FDA Announces Funding Opportunities for Medical Device Development Tools

FDA Announces Funding Opportunities for Medical Device Development Tools     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 created in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse …

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FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices     On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system. When finalized, “Computer Software Assurance for …

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Five Most Common Compliance Problems

Five Most Common Compliance Problems     Regulatory compliance in health care is a vital part of patient care. Regulations create frameworks for best practices among different healthcare organizations. But when it comes to compliance protocols, many healthcare organizations are operating suboptimal or inefficient systems. Two of the major issues in this regard are when healthcare …

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Streamlining the Literature Review Process

Streamlining the Literature Review Process     Literature reviews play an integral role in the regulation of medical devices and technologies. We spoke with Evidence Partners’ CEO Peter O’Blenis to learn more about the challenges of literature reviews, their role in supporting patient safety and global regulatory approval, as well as new tools that help medtech …

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Elcam Receives MedAccred Plastics Injection Molding Accreditation

Elcam Receives MedAccred Plastics Injection Molding Accreditation     Elcam Medical has achieved MedAccred Accreditation for Plastics Injection Molding. It is the first company in Israel to meet the audit requirements set by MedAccred subscribing members, which include Bausch Health, Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker. The …

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Device Labeling: Best Practices

Device Labeling: Best Practices     EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and …

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The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR     Equivalence strategies can be used to efficiently demonstrate the safety of a medical device, limiting the need for new studies and testing. Given the level of investment that may be needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may …

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FDA Establishes OTC Hearing Aid Category

FDA Establishes OTC Hearing Aid Category     Consumers with perceived mild to moderate hearing impairment will soon be able to purchase hearing aids directly from stores or online retailers without a medical exam, prescription or fitting adjustment by an audiologist. On August 17, the FDA published a final rule to improve access to hearing aids. This …

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Evidence Partners AI-Based SLR Platform Attracts $20 Million in Growth Financing

Evidence Partners AI-Based SLR Platform Attracts $20 Million in Growth Financing     Evidence Partners, developer of AI-enabled literature review automation software and creator of DistillerSR, has closed a $20 million growth financing round led by Thomvest Ventures with participation from Pender Ventures and Export Development Canada (EDC). The funds will be used to accelerate global …

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CAPA Management Can Save Resources and Reduce Expenses

CAPA Management Can Save Resources and Reduce Expenses     No company can improve its performance if it does not fundamentally recognize and understand its errors and failures. This approach entails a change of mindset under which failures should not be regarded as disasters but instead reframed as areas ripe for improvement. Here is where implementing …

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