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Labelling compliance – what you need to know

In September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use.

Examination of UDI Implementation and Lessons for Manufacturers of Class II Devices

Almost two and a half years after the FDA issued its final rule on a Unique Device Identification system, the clock is ticking relentlessly towards the next critical deadline in the timetable for its compulsory introduction. By September 2016, the labels and packages of all Class II medical devices must bear a Unique Device Identifier (UDI) – and data for such devices must be submitted to the FDA’s Global Unique Device Identification Database (GUDID). The implications for medical device companies are significant.

Our UDI opinion article was published by PMPS

In September 2013, the FDA set out its framework for establishing a unique device identification system to track medical devices through their distribution and use. The system, which is being phased over several years, means that by 2020 most medical devices will need to include a unique device identifier (UDI) in human- and machine-readable form.

Prisym ID to Attend Informa's Pharmaceutical and Medical Device Labelling Summit

PRISYM ID, the leading provider of labeling solutions for the medical device and life sciences industries, is exhibiting on Stand 6 at the Informa Pharmaceutical Labeling Conference. The event takes place between the 27th and 28th October 2015 at the Maritim ProArte Hotel Berlin, Germany.

PRISYM ID is silver sponsor and speaker at medical device labelling conference

PRISYM ID, one of the leading providers of complete labelling solutions for the medical device and life sciences market, is silver sponsor at the third Annual Medical Device Global Labelling Strategies Conference, August 12-13, 2015.

PRISYM ID Named Silver Sponsor and Speaker at 2015 Medical Device Global Labeling Strategies Conference

PRISYM ID, a provider of labeling solutions for the medical device and life sciences market, has been named a silver sponsor at the third annual Medical Device Global Labeling Strategies Conference from Aug. 12-13. The two-day event is held at Double Tree, Hilton Hotel in St. Paul, MN.

PRISYM ID appoints Mike Smith as USA SVP of global operations

PRISYM ID, a leading provider of labelling solutions for the medical device and life sciences industries, has appointed Mike Smith as senior vice president of global operations.

FDA Website Tracks IDs of Medical Devices

The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But the latest FDA announcement that its online Global Unique Device Identification Database, AccessGUDID, is now available to the public and brings the labeling of medical devices under unprecedented levels of scrutiny – with ramifications not only for manufacturers, but also throughout the entire supply chain.  

Keeping Up With the New Medical Device Labeling Requirements in the US

Following the Food and Drug Administration's first compliance deadline last September for medical device makers to start labeling their products with a unique device identifier, many manufacturers will have been persuaded to review their current labeling capabilities. Achieving zero defect labels is not a "mission impossible", says PRISYM ID's Dave Taylor.

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