International regulators agreed on a set of principles for building a harmonized Global UDI system throughout the medical device supply chain. Today, variances between medical device regulations in some jurisdictions has impacted the supply chain. Learn how to overcome these challenges and to take advantage of the opportunities a Global UDI system brings to manufacturers and hospitals.
This webinar will discuss:
The importance of the UDI device triggers, data quality requirements and validation rules.
Master data management and how to support data registration to numerous regulatory databases.
Maintaining globally compliant labels and the impact of regulator and manufacturer actions on the adoption of UDI across the device ecosystem.
Ideas to reduce variability and increase the value of the device label as a communications tool.
A quick, condensed, and powerful PowerPoint style overview of Innovatum as a company and their ROBAR Enterprise Labeling System including topics such as: Company Overview, Notable Customers, and Efficiencies Gained Through the System.
Additional areas covered include, Label Creation and Process Controls, Artwork Management, Management of Raw Data / Metadata, Multi-User Electronic Label Approval, Redlining, Batch Record Creation Issuance, Label Reconciliation, Traceability, Destination Labeling, Labeling System Architecture, 100% Automated Print Inspection, Scalability and High Availability, Ease of Integration, Data Push and Pull Capabilities, Maintenance and Support.
Innovatum ISO 9001:2015 Certification Announcement
Innovatum, Inc. is pleased to announce ISO 9001:2015 Certification by an ANAB accredited body for its quality management system for software development, delivery, and support as a Life Sciences software provider. ISO 9001 is the International Standard for Quality Management Systems. Innovatum’s commitment to quality is now substantiated by ISO 9001:2015 Certification. This development demonstrates an exciting and documented level of quality assurance for Innovatum as a labeling, regulatory data management, and submissions software company. Innovatum constantly sets the bar higher for similar companies in the industry.
Innovatum and EU/MDR IVDR Solutions at 2018 UDI Conference
As a proven provider of UDI solutions, Innovatum will be discussing EU MDR/IVDR considerations based upon experience and information gained by working with leading life sciences companies and through leadership in AIM. Considerations for challenging aspects of compliance such as destination labeling, implant card, eIFU management strategies and automated label print quality management will be addressed and demonstrated. Drop by Booth #19 at the 2018 UDI Conference in Baltimore, MD on April 24-25, 2018 to join in the discussion, learn and share your experiences.
The answer to that question in a word is yes, life sciences labeling is immeasurably complex. To provide you with an illustrative contrast based upon my decade of experience within the field of information security, life sciences labeling is a far more complex subject than an area such as Cyber-security technologies. If you think my previous statement is off-base, then keep reading. In addition to being exceptionally complex, labeling within the Life Sciences is also a mission critical function that is constantly changing as regulatory requirements are increasing exponentially around the world. Since the U.S. FDA considers the label to be part of the product, if products are not being properly labeled, those products must not be shipped. A product that is incorrectly labeled has the potential of causing injury or death. Labeling systems must also be extensible to accommodate new data in a flexible way as requirements will constantly continue to change.
Jack Mazur, Principal JMG Recruiting, Pete Ginkel, Vice President ID Integration, Inc., and Lisa Fohey, CMRP PMP Director of Supply Chain Children’s Hospital of Wisconsin will be conducting a UDI Webinar hosted by JMG Recruiting from 1:00 pm to 2:30 pm Eastern on Wednesday January 6, 2016.
Topics to be covered include Direct Part Marking technologies & application – The speaker will review the popular marking technologies for Direct Part Marking of Medical Devices. The technologies reviewed will include:
Electrochemical etching, Laser marking, and Dot peen marking
How can healthcare providers maximize the value of UDI in the healthcare supply chain? This presentation will explore the challenges providers encounter as they prepare to implement UDI: technology shortcomings, competing priorities for resources, difficulty in creating a sense of urgency.
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