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Explore the transformative impact of additive manufacturing on medical devices, including design flexibility and materials.
Learn about outsourcing options in the medical device sector, focusing on quality, compliance, and operational excellence.
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Stay informed on best practices for packaging and sterilization methods that ensure product safety and compliance.
Explore the latest trends in research and development, as well as design innovations that drive the medical device industry forward.
Discover the role of software and IT solutions in enhancing the design, functionality, and security of medical devices.
Learn about the essential testing methods and standards that ensure the safety and effectiveness of medical devices.
Stay updated on innovations in tubing and extrusion processes for medical applications, focusing on precision and reliability.
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Read the editor’s thoughts on the current state of the medical device industry.
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125 Highpower Road , Rochester, NY, 14623, US
We have extensive regulatory experience with the FDA and regulatory bodies worldwide. Test protocols and final reports follow the most current national or international standards, are tailored to each device, and have a long history of acceptance by the FDA during a 510(k) review. HIGHPOWER Labs is an ISO 17025 accredited laboratory and is ASP factory trained to perform STERRAD® functionality and efficacy validation testing. We provide a wide range of verification, validation and testing services, as well as consulting services to medical device manufacturers.
Regulators are raising the testing bar by demanding the rationale behind verification efforts.
By: Michael Barbella
Intrinsic radiologists will provide guidance to the trial sponsor on the imaging charter.
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