Archive for July, 2011
Tuesday, July 26th, 2011
FDA has issued draft guidance to help medical device manufacturers understand when a change to a previously cleared 510(k) device may require a new premarket notification submission. According to the agency, most packaging changes do not require a new 510(k). But there are some areas you should study closely.
In the ...
Posted in FDA, Labeling, Medical Devices, sterilization | 1 Comment »
Friday, July 22nd, 2011
TEQ (www.teqnow.com) has tapped the expertise of Spartan Design Group (www.spartandesigngroup.com) to help OEMs with their medical packaging system designs and conformance to EN/AAMI/ ISO 11607 Parts 1 and 2.
Spartan will be advising customers in package system development in areas such as Sterile Barrier System (SBS) stability testing, package system ...
Posted in Design, Medical Devices, Quality, standards, Testing | No Comments »
Monday, July 18th, 2011
We hope you were able to tune in to our Webcast, "Trends in Orthopedic Device Packaging." We thank our speakers Rod Patch, Sarah Grare, and Scott Hall for their efforts, our sponsors Beacon Converters, Multivac, Plastic Ingenuity, and Rollprint Packaging Products for supporting the event, and you, the audience, for ...
Posted in FDA, Handling, Hospital, Medical Devices | No Comments »
Tuesday, July 12th, 2011
During a policy forum held today in Washington, DC, the Pew Health Group introduced its report, "After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs." Referring to the heparin-contamination case as a "wake-up call" to supply-chain risks, Allan Coukell, Pew's director of medical programs, said that while ...
Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Hospital, Imports, Inspection, Medical Devices, Medical Errors, Safety, security, serialization, standards, supply chain, Tampering, Theft | 1 Comment »
Friday, July 8th, 2011
This week we saw some U.S. congressional activity regarding pharmaceutical supply-chain safety. Legislators recognize that FDA or other federal agencies need more authority to crack down on substandard or counterfeit drugs. Could we be nearing legislation?
For instance, yesterday the Committee on Homeland Security's Subcommittee on Oversight, Investigations, and Management held ...
Posted in Counterfeiting, Diversion, FDA | No Comments »
