Med Device Labels – More languages and Symbols? Here Is a Solution

Destination Labeling, also known as Local Language Labeling, Just-in-Time labeling, Regionally Specific Labeling, etc. addresses the challenges that most manufacturers in the life sciences industry are presently struggling with.

Having great solutions for these labeling challenges is one thing, conveying the concepts is another. That is why Innovatum has produced three short new videos. This first video describes our DL solution.


EC Outlines Rules for Electronic IFUs

On December 14, 2020, the EC outlined rules for electronic IFUs. The question now becomes . . . what are the implications of this?

Simply put, taking advantage of the cost savings and risk reduction inherent with moving to eIFUs involves two primary areas of consideration. Specifically:

  1. Delivery of the eIFU service itself and . . .
  2. Delivery of the labeling related changes that must coincide with other changes.

Delivery of the IFU

Pre-launch activities involve:

  • Planning
  • Reviewing internal quality procedures
  • Risk Assessment
  • Implementation
  • System Validation

Providing quality on-going eIFU services involves:

  • A multilingual website interface and multilingual phone services provided worldwide that is free of charge for callers.
  • Delivery of paper based IFUs free of charge to requesters within 7 days of request.
  • Archived eIFUs in some cases, being made available for a periods of up to 15 years.
  • Maintaining a system to clearly indicate when the eIFUs have been revised and it must inform each user of the device if the revision was necessary for safety reasons.
  • Verifiable levels of security and high availability for the eIFU hosting website.

Delivery of labeling changes

The associations between products requiring an eIFU, the versions of eIFUs and also patient facing information must be managed. This endeavor includes the translations of various languages and the replacement of existing versions of electronic documents. And this occurs whenever new documents have been created, reviewed, approved and readied for posting. Multiple documents may need to be related to the same products and printed at packaging time. Also, changes must be made to actual product labels to indicate that an eIFU is available. A strong Destination Labeling component has the ability to tie everything together and accomplish all of this nicely through automation.

The ROBAR system by Innovatum with its associated delivery and support services eases the transition to eIFU. Associations between products, various IFU and eIFU versions, languages and on-going histories of prior versions are stored in the ROBAR Master Data Management database. This is exactly what is needed for accurate and efficient Destination Labeling. Data is used to update hosted web based systems to ensure that the most current, approved, version specific, language specific and historically tracked information is made available appropriately.


Innovatum Sponsors UDI Beyond the Basics Masterclass

As a contributing member of AIM, Innovatum invites you to take advantage of this free 2-hour UDI Masterclass we sponsored that was conducted by FDA and noted industry experts including Jay Crowley and Terrie Reed.

The Seminar recording is now available along with the session slide decks.
https://www.aim-na.org/udi-work-group.html

UDI SEMINAR TIMESTAMPS
1:41 – Unleashing the Potential of Medical Unique Device Identification | James Tcheng, Duke University Health
28:17 – Challenges with UDI Implementation | Jay Crowley, USDM and Dennis Black, BD
55:48 – UDI Panel – Vision and Reality | Patti Blessing, CAVU; Terrie Reed, Symmetric; Natalia Wilson, Arizona State University; Olga van Grol-Lawlor, Boston Scientific

Regulatory bodies, device manufacturers, healthcare providers and numerous other stakeholders are gearing up for global implementation which presents its own specific challenges and opportunities. Adherence to specific regulatory specifications, both in labelling and packaging as well as data is a must, but in an increasingly competitive market, achieving compliance while maintaining a competitive edge and assuring ROI is paramount. This recorded Seminar highlights the state of urgency in the industry, addresses implementation challenges – plus helps you to maximize the ROI of your UDI implementation in the future, ensuring it continues to drive business value.


Considerations for End-To-End Labeling Implementation & Optimization (Video)

A joint case study presentation “CONSIDERATIONS FOR END-TO-END LABELING IMPLEMENTATION & OPTIMIZATION” by Aimee Wright- Labeling Manager, Global Labeling Zimmer Biomet and Ardi Batmanghelidj- President and CEO.  The session conveys real-world scenarios and covers topics such as:

  • Comparing varying perspectives into end-to-end labeling
  • Needs assessment: Full implementation versus upgrade
  • Technology solutions & related cost considerations
  • Common execution missteps & lessons learned

 


Innovatum- Platinum Sponsor Of the Q1 11th Annual Medical Device & Diagnostic Labeling Conference

9th Annual Q1 Device Diagnostic Labeling ConferenceSugar Hill, Georgia 09/08/2021

Innovatum is proud to be the Platinum Sponsor of the Q1 11th Annual Medical Device & Diagnostic Labeling Conference taking place September 22-23, 2021 in a virtual meeting format.

The event is open for registration at: https://www.q1productions.com/medical-device-labeling/ and highlights perspectives from regulatory authorities and industry experts to support your team’s labeling quality and compliance. Enter the discount code INNOVATUM to receive 20% off of the registration price.

A joint case study presentation “CONSIDERATIONS FOR END-TO-END LABELING IMPLEMENTATION & OPTIMIZATION” by Aimee Wright- Labeling Manager, Global Labeling Zimmer Biomet and Ardi Batmanghelidj- President and CEO, Innovatum begins at 11:00 Central on day two of the conference September 23, 2021.  The session conveys real-world scenarios and covers topics such as:

  • Comparing varying perspectives into end-to-end labeling
  • Needs assessment: Full implementation versus upgrade
  • Technology solutions & related cost considerations
  • Common execution missteps & lessons learned

This conference is an opportunity to participate in an on-line format with a diverse set of sessions on a variety of topics pertaining to regulatory and labeling concerns for the life sciences industry. The virtual format improves accessibility to the latest information without a need to travel.
We hope you are able to attend.