Innovatum defines alliances as ongoing relationships for which we have recognized tangible synergy across the capabilities and offerings of the companies that we are aligned with. Through the awareness brought about by these alliances we are able to offer a more fully-featured solution set for our customers.
The Innovatum alliance process includes:
- A candidate vetting process of the potential alliance company
- Cross-training on the solutions and offerings that are available between our companies
- Formal and informal announcements for each alliance
Please contact Mark Sikorski firstname.lastname@example.org if you feel that your company may be a good candidate for becoming an Innovatum Alliance.
Headquartered in Geel, Belgium, Qarad provides manufacturers of medical devices with the necessary services to obtain the CE mark and quality system certification (ISO13485) and acts as an Authorized Representative for non-EU manufacturers. From this regulatory background, Qarad developed its e-IFU Service consisting of a validated website and worldwide multilingual free telephone system, in full compliance with European, FDA and other national regulations. Qarad is an ISO13485 certified company. Paper leaflets can be a thing of the past. The end-user of the IVD or MD can download the right instructions from a website or can ask for the e-IFU by calling a free telephone service, without your intervention needed.
In Annex I, Chapter III, Point 20.1 of the regulation for IVD’s or Annex I, Chapter III, Point 23.1 of the regulation for MD’s is written:” Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website…”
The European guidance document MEDDEV 2.14/3 rev. 1 describes the conditions in which manufacturers of IVD products can make Instructions for Use available to the user. These include:
- IFUs must be on a dedicated website or a dedicated area of a website
- Data security requirements
- Users must have the opportunity to ask a copy of the IFU by calling a free telephone number
- The system must be based on risk management principles.
EU Regulation 207/2012 describes the conditions in which manufacturers of MD products can make Instructions for Use or e-IFU available to the user.
Argos Multilingual is a global language solutions provider with experience servicing clients in the life sciences, industrial manufacturing and software/hardware industries. Our business is built on three core values: Quality at Source, Partnership Approach and Technology Agnostic Solutions, as we are committed to giving you choice while providing the best customized strategy to fit your business needs. We are ISO 9001, ISO 17100 and EN ISO 13485 certified. With production centers in Krakow, Poland and Kansas City, USA we bring value to you through our dedicated customer service and subject matter expertise for your specialized industry.
QuickLabel Systems innovates label printing solutions for manufacturers who require the flexibility to print product labels in-house. Innovatum’s ROBAR software and QuickLabel’s Kiaro! inkjet label printer, create a complete, onsite solution for printing and controlling medical device labels. QuickLabel’s Kiaro! is used in numerous medical device and pharmaceutical manufacturing environments. When used with ROBAR, the Kiaro! prints FDA-compliant color labels on-demand, including UDI labels. It is integral to an on-site control and risk reduction system that produces unique labels at the point of application.
AIM NA Healthcare Committee
Implementing AIDC can be a challenge in any environment. Combine that with the regulatory requirements of the life sciences and healthcare industry, and the challenges may at times seem insurmountable. The AIM North America Healthcare Committee was formed to assist with the implementation of auto ID in these regulated environments. The committee is comprised of veterans of the industry, each with several decades of experience. Some of the committee members have been involved in the auto ID industry since its infancy; all are current practitioners in one aspect or the other. Currently about 35 industry leading companies have multiple representatives on the committee.
Q1 Productions designs and develops webinars, training courses, conference programs and forums aimed at specifically targeted audiences throughout highly regulated industries in order to provide strategic learning and timely program content. Through a highly structured production process focused on research calls with end-users and key stakeholders in the industry, our team is able to understand the immediate business concerns of today’s leading executives. Whether focusing on new or pending legislative and health policy issues or enhanced technologies or processes that will drive efficiency, our programs provide solutions to the urgent educational and information needs of our attendees. Q1 Productions is responsible for the development of the successful Semi-Annual Medical Device and Diagnostic Labeling and Medical Device Packaging Conferences. Every year labeling and packing professionals from the medical device industry attend our conferences to network and discuss the latest trends and solutions to their pressing challenges.
Seagull Scientific, Inc.
Seagull Scientific developed BarTender Enterprise, the global market leader in off-the-shelf bar code and RFID label design software. Seagull is also the world’s leading developer of Microsoft-certified Windows Printer Drivers for industrial-grade bar code and RFID label printers, with support for over 1,500 printer models from 45 different manufacturers around the globe. Innovatum integrates BarTender Enterprise and Drivers by Seagull as the label design and print engine in ROBAR.
Medical Tracking Solutions, Inc.
Medical Tracking Solutions, Inc. was established by an experienced team of industry professionals with expertise in the areas of medical device sales, distribution, logistics, loaner kit processing, and software development. With an intimate understanding of the challenges facing the medical device industry, MTS was inspired to develop iTraycer to solve the many problems associated with field inventory, multi-level bill of material tracking, and mobile inventory.
iTraycer is a comprehensive inventory management system that provides real-time medical device tracking, as well as biologics tracking – giving visibility to part, lot, and serial numbers – from manufacturer to patient.
Celer Pawlowsky, SL
CPSL is a leading language services company that caters for the full life cycle of multilingual software, documentation and content. We have a global team of around 1450 translators, interpreters, Desk Top Publishers, localization engineers and project managers. CPSL translates 60 million words a year into over 30 languages and has expertise in markets including life sciences, information technology, automotive and transport, manufacturing and engineering as well as public institutions. Our service portfolio also offers full-service interpreting, transcription, subtitling, dubbing and other media-based language support. We are ISO9001, 13485 and 17100 certified and have offices in Spain (Barcelona and Madrid), Germany, UK and USA. Our clients are global and many have been with us for over 20 years. We put that down to excellent service and friendly staff. Together with our industry knowledge, we help our clients get the most out of their investment in language support