Innovatum President and CEO, Ardi Batmanghelidj, will be one of 3 subject matter experts who will be providing Regulatory insight into Packaging and Labeling, eIFU, CAPA for Packaging, UDI and MDR as part of the upcoming Orange County Regulatory Affairs (OCRA) webinar September 23, 2020.
Mr. Batmanghelidj will be discussing EU MDR, Eudamed and associated requirements as they relate to labeling challenges. These challenges primarily center around the increasing amount of data required for labels & UDI. Yet all challenges can be helped by creating a “single source of truth” through MDM architecture that enables continuous system expansion. MDM mapping with different regulatory systems worldwide rounds out the picture.
Heading up a software company specializing in labeling and regulatory compliance since 1993, Ardi has amassed extensive hands-on experience in the Life Sciences industry. He has continuously shared his expert guidance with the FDA and manufacturers in the areas of master data management, labeling and barcoding. Ardi is presently contributing to the MedTech Europe working group for EUDAMED machine to machine communications.
Attendance at the webinar awards 2 hours toward your RAC certification. The Discount Code to attend this webinar FREE of charge is: INV3
Click here for registration instructions, speaker schedules, and all Abstract details.
A regulatory driven, product design tsunami is headed our way, but at least we have an awareness that it is coming and a means of preparing for it. New requirements for destination labeling, brought about by globalization, are on a collision course with the applications of technology that we have become accustomed to. Global UDI initiatives and burgeoning breakthroughs in patient-specific modalities only add to the impact by adding to the complexity of compliant distribution worldwide. It is time to embrace a new paradigm for product design and labeling to maximize efficiency, while meeting compliance requirements for the future. While just-in-time manufacturing is here to stay, on-demand localizable labeling is quickly becoming a reality for companies that wish to remain competitive in a swiftly changing world. But patient-specific product design implies a more focused level of labeling for each unit of production. To make sense of all of this, we need to think in terms of finding a common denominator to solve these challenges. The common denominator is data.
Read the full article from Advantage Business Media.
Innovatum, a proud sponsor of the 9th Annual, Q1 Medical Device and Diagnostic Labeling Conference in Chicago, May 14-15, invites you to join this conference at a significantly discounted rate.
This conference with will delve into labeling strategy streamlining and optimizing in a rapidly evolving international regulatory environment with a focus on developing EU MDR and IVDR compliant labels, all while enhancing localization and translation processes, with the goal of reaching operational excellence through the implementation of impactful ELS, CMS and MDM technology.
Innovatum will be presenting a detailed review of the topic of EUDAMED based on published content and capabilities needed to support the required functionality.
Features of the Conference will include:
- Deep Dive into EU MDR & IVDR Impact on Labels
- IFU Content Optimization: Human Factors & Technical Writing
- Tech Talks: Opportunities in Label Optimization Technology
- Beyond EU: International Labeling Concerns in China & Russia
- Maximizing Label Content Localization through Flexibility
- Enhancing eLabeling Strategies for US Based Products
Innovatum has negotiated a $300 discount for our customers, colleagues and friends.
Enter “INNOVATUM” in the discount code field on the second page
Share this link with anyone you wish. We look forward to seeing you there!
Innovatum Named as a Major Player in the IDC MarketScape
Innovatum, with our emphasis on life sciences, is pleased to be named as a major player in the IDC MarketScape: Worldwide Enterprise Labeling Application 2018 Vendor Assessment.
Click the link below to find out more:
The new EU Medical Device Regulations: learn more about the new MDR and its impact on your translations. Download the FREE Whitepaper from Innovatum’s Partner Argos Multilingual!
This free Whitepaper will give you information about:
- The scope of the regulation
- Why the changes happened
- What happens when – dates for compliance
- How to prepare for these upcoming changes
- How it will impact your multilingual content
If you have further questions, please contact us at (877) 277-3016.
Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI.
“But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and Unique Device Identification (UDI) compliance. “In contrast, it is just beginning.
“Although many medical device manufacturers have complied, on-going maintenance for previously submitted UDI data will soon be enforced,” he tells PMP News. “And the regulatory requirements of UDI variants by regulatory bodies around the world will continue to make global UDI compliance a challenge for quite some time.”
Batmanghelidj explains 5 common UDI challenges and potential solutions.
Communication. One of the challenges arises from miscommunication of labeling data. “Most medical device manufacturers inexplicably approach UDI by separating it into two different projects that are managed by two different departments,” Batmanghelidj says. “The labeling team is responsible for UDI data on the label, and the UDI team is responsible for UDI data management and submissions. Yet, most of the data overlaps and must be kept in sync! Think of a row in an Excel spreadsheet that contains fields with labeling specific data for an item. Now think of adding additional columns to house regulatory data within that same row. Since some of the data within that row is placed upon sticky labels and some of that very same data is also being submitted to regulatory bodies, this data can be stored once and reused. This ensures data quality. The problem of having to prevent a likely mismatch between the information that is submitted and the information used on the label is now gone. With an extension to what is traditionally considered to be enterprise labeling software, it is now possible to bring these capabilities to life.”
Read the full article from Packaging Digest.
Sugar Hill Ga April 11, 2018
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 UDI Conference allows you to hear about solutions and approaches from other companies that are similar to yours and interact directly with the FDA UDI team. Examine the agenda at www.udiconference.com/UDI_Conference/ and register at www.udiconference.com/UDI_Conference/registration/ Remember to enter “INN” in the discount field for $100 off of the published rate.
Microscan, a global technology leader in barcoding, machine vision, verification, and lighting solutions, will partner with Innovatum, a leading regulated labeling software and consulting services company for life-sciences, to present a fully integrated label inspection technology helping life-science manufacturers assure that all product labels are correct and barcodes meet quality grading requirements. Although scanning technologies and software for barcode verification have been around for quite some time, this fully automated closed-loop solution saves set-up time, boosts productivity of label management and inspection processes, and ensures that the risks and costs associated with mistakes and poor quality of the labels are minimized.
Innovatum will be demonstrating the integration of its ROBAR Labeling system with Microscan’s LVS-7510 print quality inspection solution embedded within a Zebra printer from the Booth #7 at the Global GS1 Healthcare Conference taking place in Chicago, IL on October 17-19. This breakthrough development is a fully automated complex solution that checks the entirety of label data to ensure data on that label is based on the information received from the Automated ID and Data Capture part of the system and is a match to the ROBAR labeling database.
To read the full article, click here.
This month, Innovatum further demonstrates its leadership role in the Life Sciences labeling niche, regulatory data management, and submissions by contributing the cover feature article in Medical Design Briefs and an article in Medical Design Technology.
As medical technology accelerates at an almost incomprehensible pace, regulations and requirements increase correspondingly. With rapid innovation and the desire to speed time to market comes more rigorous requirements for safety and effectiveness, which drives the establishment of programs such as FDA’s unique device identification (UDI) system. UDI is designed to identify medical devices through their distribution and use in their labeling and to report certain information via publicly accessible database.
Read the full article here: http://viewer.zmags.com/publication/685a60a7#/685a60a7/12
Keeping with Innovatum’s commitment to deliver the highest level of customer service, we have teamed with Oracle and it’s Cloud Platform to provide easy access to our labeling solutions in a highly secure, easily available cloud environment. The Oracle Cloud Platform provides customers, partners, and developers with everything they need to build, deploy, and extend applications and run business-critical workloads.
“Our market is changing, and so must our industry-leading life science labeling solutions. So we decided to start delivering our ROBAR service via the cloud to make it easier for new customers to access our world class labeling solutions. For us, high availability, reliability and security are top priorities, especially in the highly regulated industry in which we operate,” said Ardi Batmanghelidj, president and CEO, Innovatum. “We considered several solutions, including Amazon, but chose Oracle Cloud Infrastructure as a Service due to Oracle’s reputation as a leading technology provider. Oracle’s focus on security helped to tip the scales, along with the cost-effectiveness of its offerings.”
Innovatum is well-known for keeping up with significant changes in the market and ensuring that our client’s needs our met, especially as it pertains to accessing our life sciences labeling solutions. Adopting Oracle’s Cloud Platform provides Innovatum and clients with the highest level of security and availability to its market-leading life sciences labeling solutions.
Begin a no-obligation conversation by calling 877-277-3016 or clicking here.