Medical Innovation Exchange

compliance

Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market

Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market     The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and …

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Regulating Point of Care Printed Devices

Regulating Point of Care Printed Devices     The use of 3D printing for medical devices opens tremendous opportunities in health care. It allows users to test and adjust components more quickly than traditional manufacturing and enables the creation of personalized products, such as custom prosthetics. However, questions remain about what oversight the FDA will have …

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Risk Management Is More Than a Spreadsheet

Risk Management Is More Than a Spreadsheet     In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we will look at how a change from a document-driven risk management approach to a data-driven risk management approach can help mitigate product failure. Mitigating risk …

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RQM+ Appoints Mahofski as Head of Mergers and Acquisitions

RQM+ Appoints Mahofski as Head of Mergers and Acquisitions     Ronnie Mahofski is the new head of mergers and acquisitions (M&A) at RQM+, a global provider of MedTech regulatory and quality experts. Mahofski has more than 20 years of experience in the MedTech industry and has held various positions at RQM+, including overseeing M&A integration …

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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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