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Software & IT
Six Document Control Problems for Medical Device Firms to Avoid
Homegrown systems and paper-based processes can create unnecessary risk for medical device companies when it comes to document management. From policies to manuals, regulatory reports to standard operating procedures (SOPs), these companies deal with…Rachel Beavins Tracy, EtQ 09.01.17
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Software & IT
Integrating Training and Document Control with Automated Solutions
Companies today use many methods to maintain compliance with safety and quality regulations. Typically, training employees to maintain compliance can easily be reported on a metrics dashboard as “red, yellow, or green” and is the most eff…Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 04.03.17
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R&D & Design | Software & IT | Testing
FDA Updating Guidance on 510(k) Submissions for Product Software Changes
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” This new guidance document applies to software changes only, and addresses t…James A. Dunning, CEO, QPC Services 10.12.16
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Contract Manufacturing | Software & IT
Tools for Maintaining an Audit-Ready State to Ensure Compliance
In the last three years, the U.S. Food and Drug Administration (FDA) issued more than 30 warning letters and 483 form inspectional observations related to electronic records. It appears the medtech industry is not sure how to comply with FDA inspecti…Emily Ysaguirre, VERSE Solutions 06.09.16
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Cardiovascular | Contract Manufacturing | Materials | Testing
Sterilization Innovations Lead to New Guidance Document
It took more than seven years, but the U.S. Food and Drug Administration (FDA) has, at long last, released a final version of its 2008 draft guidance on sterility data needed for 510(k) product submissions. Issued Jan. 21, the guidance applies to med…James A. Dunning, QPC Services 05.06.16
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R&D & Design | Software & IT
FDA Releases Cybersecurity Guidance Document
Protecting patients by safeguarding device security is the key focus for a new U.S. Food and Drug Administration (FDA) guidance document. Preventing unauthorized software changes and ensuring that patient-specific data is secure are both central topi…11.13.14
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FDA Document Leak Reveals Agency “Spies” on Employees
Senator puts pressure on FDA to explain itself.Niki Arrowsmith 07.18.12
