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USDM Life Sciences: August 2014

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Friday, August 29, 2014. Do Manufactured Parts for Medical Devices Need a UDI? If you are manufacturing and selling a part of a medical device to another manufacturer (not a complete device), the package does not need a UDI. However, the fully assembled device will need a UDI for distribution. Will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI. Thursday, August 28, 2014. Singe device is not intended for distribution. Will help you assess...

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USDM Life Sciences: November 2013

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Monday, November 25, 2013. Validation Considerations for Mobile Devices. The rapid advent of wirelessly networked mobile devices such as tablets and cell phones into FDA regulated business processes has created significant challenges for the legacy based IT platform qualification and validation regimens. These known-state validation frameworks were defined during the prevalence of dedicated single purpose backend IT resources, coupled with traditional PC based user interfaces. Provision of policies and p...

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USDM Life Sciences: July 2014

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Thursday, July 24, 2014. Drug Supply Chain Security Act (DSCSA): Are the Required Data Elements in the Data Matrix for 2017 Consistent with Previous Guidance Document on SNI? The USDM Life Sciences. Track and Trace Solutions and Services. Wednesday, July 23, 2014. Drug Supply Chain Security Act (DSCSA): What Deadlines Occur Between 2017 and 2023? The USDM Life Sciences. Track and Trace Solutions and Services. Tuesday, July 22, 2014. The USDM Life Sciences. Track and Trace Solutions and Services. Track an...

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USDM Life Sciences: Does FDA Require the Investigator to Complete an FDA 1572 for Conducting Clinical Investigations of a Medical Device?

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Monday, March 16, 2015. Does FDA Require the Investigator to Complete an FDA 1572 for Conducting Clinical Investigations of a Medical Device? For clinical investigations of medical devices, an FDA 1572 is not required. However, an investigator agreement is required for clinical investigation of medical devices. An investigator agreement is not a specific form, it’s an agreement of the PI to conduct the trial according to regulations. Subscribe to: Post Comments (Atom). Is There a Checklist for GCP Audits?

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USDM Life Sciences: September 2014

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Friday, September 12, 2014. Accredited Issuing Agencies for UDI. As of September 2014, there are three issuing agencies for UDI that have been accredited by the FDA. Issuing agencies operate a system for assignment of UDIs. The US. FDA UDI Final Rule indicates that not all product types need to have the same issuing agency, so medical device companies can use more than one. Each issuing agency operates differently, so make sure you understand how your company would implement the standards for each agency.

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USDM Life Sciences: January 2014

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Monday, January 6, 2014. Sales of Counterfeit Drugs on Rise. Getting a prescription filled at a cheaper online pharmacy is tempting for many of us. But, if your online pharmacy is not verified, there’s a chance you are being ripped off or worse yet, putting your life in danger. The World Health Organization reports that in more than 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit. Thursday, January 2, 2014. A cri...

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USDM Life Sciences: Does the UDI Extension for Some Implantable Devices Apply to All Class II (FDASIA) Devices?

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Friday, March 13, 2015. Does the UDI Extension for Some Implantable Devices Apply to All Class II (FDASIA) Devices? The extension for some implantable devices does not apply to all class II (FDASIA) medical devices. The extension only applies to devices that are classified as FDASIA implants and distributed non-sterile. It’s a limited subset of all FDASIA devices that have been granted this label extension to 2016. Our team of UDI. Subscribe to: Post Comments (Atom). Is There a Checklist for GCP Audits?

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USDM Life Sciences: Is There a Checklist for GCP Audits?

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Thursday, March 12, 2015. Is There a Checklist for GCP Audits? There are a number of GCP audit checklists, some of them are available for free online. An Internet search for “GCP audit checklists” will provide you with many checklists to choose from. The auditors at USDM Life Sciences recommend including a checklist as part of your quality assurance process – don’t wait until you get an audit notice to prepare. Perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.