Since the introduction of UDI by the FDA (U.S. Federal Drug Association) a demanding series of requirements have been laid down for manufacturers of medical devices. There is however, still some ambiguity relating to the implementation of product labelling. Manufacturers must not only make their products UDI compliant, legible and securely traceable, they also have to adapt and validate their manufacturing processes at the same time.
To aid medical device manufacturers navigate the many challenges presented by UDI, Bromsgrove based TLM Laser have announced a symposium which will discuss the quality management and technical implementation requirements, and provide expert advice on what a UDI compliant solution should look like.
This one-day event, to be held on the 21st March 2018 at the South Court Hotel, Limerick, Ireland, will spotlight the issues around UDI and cover topics such as risk classes, deadlines for compliance, impacts on quality management, together with advice on the technical implementation of UDI marking in production processes. There will also be a presentation on best practice examples of UDI in production.
Speakers at the event will include TLM Laser Director Andy Toms and representatives from laser marking experts, ALLTEC GmbH | FOBA Laser Marking + Engraving. In addition to the programme of presentations, there will be a practical demonstration on how vision-aided laser systems can help build a more robust and cost effective UDI marking process. A FOBA M2000-P laser marking system with IMP (Intelligent Mark Positioning) will demonstrate: part validation, pre-mark verification, automatic mark alignment, mark verification and OCV and 2D code validation.
(A live demonstration of UDI compliant marking with FOBA’s M2000-P will be a key element in the TLM Laser symposium on UDI)
The event will be of specific interest to manufacturing and quality engineers from medical sector manufacturing companies within the UK and Ireland and interested parties can register for the event at:
https://tlm_laser_udi_symposium.eventbrite.co.uk
Alternatively contact TLM Laser by E-Mail: [email protected] or speak with Andy Toms at TLM Laser for more information and a copy of the event programme. TLM Laser is the UK and Ireland distributor for ALPHA Laser and FOBA Laser and offers a comprehensive range of laser welding and marking machines and systems.
For further information, please contact:
Mr Andy Toms
Director
TLM Laser
2 Navigation Court
Harris Business Park
Stoke Prior
Bromsgrove
B60 4BD
Tel: +44 (0)1527 959 099
E-Mail: [email protected]
Web: www.tlm-laser.com
