13th Annual

Medical Device & Diagnostic Labeling Professional Education Course

September 19-20, 2023 | Virtual Event

Enabling Efficient Methods to Remain Abreast of Continuously Evolving International Requirements & Swiftly Integrate New Provisions with an Ongoing Focus on Europe, all while Optimizing Localization Strategies & Enhancing Processes via Enterprise Labeling Systems

Program Overview

This event highlights perspectives from regulatory authorities and industry experts to support your team’s labeling quality and compliance. In diverse sessions on labeling requirements and process changes, including international UDI rules, EUDAMED submissions and the applicability of e-labels across global regions, attendees walk away with actionable insights to ensure success. Dive deep into new and evolving industry standards with peers and glean lessons learned for future market expansion.

The dynamic Q1 Productions virtual platform fosters a sense of collaboration. Thoughtfully designed networking features connect you with your peers beyond the capabilities of a Zoom meeting. Customize your experience and address your unique concerns during live Q&A after each session. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session formats to increase interactivity and strategy-building.

Countdown to the Medical Device & Diagnostic Labeling Professional Education Course

Day(s)

Hour(s)

Minute(s)

Second(s)

Experience the Quality First Difference.

Learn from Industry Leaders

An exclusive experience with professional thought leaders provides you with direct insight into current solutions.

Keep up with Industry Trends

Learn through dynamic panel discussions, case studies and real world evidence on current topics directly related to your industry.

Exchange Ideas & Network

We provide a platform for your team to ask questions with experienced industry experts. The key to building your knowledge and seeing things from another perspective.

Find Solutions that Work for You

Insight and interaction are at the ready for you and your team. Collaborate with your peers, utilizing their insight and experience to accommodate your common challenges.

“It was a fun to be part of a well-organized event and in the company of knowledgeable industry professionals, thanks again!”

Andrew Surprenant, International QA Compliance Manager, Instrumentation Laboratory

Distinguished Presenters Include:

Jane Li
IVD Product Reviewer
GMED NORTH AMERICA

Adam True
Lead Auditor, MHS
TÜV SÜD

Irene Hsieh
Sr. Director of Regulatory Affairs & Clinical Affairs
EUROIMMUN

Roger Peterson
Senior Manager, Global Labeling, Regulatory
ARTHREX

View Full Agenda

Join our LinkedIn Group to stay up-to-date on all things Medical Device Labeling

The Q1 Productions Virtual Event Experience

Are You a Solution Provider?

Reach out to us here.

Our Sponsors

“Excellent meeting with good speakers and brilliant discussions. Liked the interactive atmosphere and the opportunities to discuss with peers how they prepare for the new legislation. The meeting was ran very professionally.”

Attendees by Job Title

Director

Manager

Other

Attendees by Company Size

More than 10k

1k - 10k

Less than 10k

Attendees by Years of Experience

20+ Years

15-20 Years

10-15 Years

Less than 10 Years

Attendees by Industry:

Medical Device

Diagnostic

Other

Reach out to us with any questions.

Our team will respond promptly!

Chris Cockerell
Senior Event Manager
Q1 Productions
+1 (312) 224-8722
ccockerell@q1productions.com

www.q1productions.com

NLG, a Welocalize company, is a provider of expert language services for global life sciences companies, including medical device, diagnostic and pharmaceutical solutions. NLG is supported by a valuable network of medical and regulatory translation, localization, and globalization experts delivering quality-centric solutions to global brand leaders in the life sciences sector. Our team prides itself on its understanding of the demanding medical device and diagnostic industry, while also providing our clients with highly personalized services. By utilizing our resources to implement the tools, services, personnel, and technologies required we can ensure our clients meet their business objectives.

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Oberon Technologies is an expert systems integrator and online delivery solution provider with a proven track record of success and the highest integrity. Oberon helps clients address all their content needs for authoring, publishing, content management, delivery and translation. Whether it is information posted online, in packaging and labeling, on eIFU sites, in technical manuals, or output in a variety of formats, Oberon offers strategies and solutions to address your needs. Oberon partners with its clients to identify and implement solutions that reduce costs, lower risk of non-compliance, and improve operational efficiencies across the content lifecycle.

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Innovatum’s ROBAR provides many powerful regulatory data management, labeling and submissions capabilities for UDI/MDR/IVDR/Eudamed. It is delivered with consulting, Implementation, validation documentation and optional validation assistance. As a true end-to-end regulated labeling system provider, Innovatum has been a top innovator in life sciences labeling for over 25 years. Innovatum’s fully configurable and easily validatable RIMS/PIMS/MDM labeling systems are easily expandable to meet future regulatory needs without involving the IT department. Additional modular capabilities include 100% label inspection and eIFU management with hosting.

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Loftware is the leading cloud-based Enterprise Labeling and Artwork Management provider. Supporting the life sciences industry in both labeling and regulated content management, we offer an end-to-end labeling solution platform for companies of all sizes. Loftware enables supply chain agility, supports evolving regulations, and optimizes business operations for a wide range of industries.

Maintaining a global presence with offices in US, UK, Germany, Slovenia, China, and Singapore, Loftware boasts over 35 years of expertise in solving labeling challenges. Our unique products and technologies are used to help companies improve accuracy, traceability, and assure compliance globally while improving the quality, speed, standardization, and efficiency of their labeling.

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enLabel Global Services, Inc. makes labeling and packaging simple and compliant. We deliver best-in-class technology, professional services and domain expertise for Compliance Labeling, Data and System Harmonization, Automation, Verification and Solution Validation. enLabel IPM provides end-to-end visibility and control of labeling operations across the global supply chain to manage perpetually changing regulatory, product, branding and localization requirements.

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RWS Regulated Industries is a highly specialized division of RWS, a world-leading provider of technology-enabled language, content, and intellectual property services. The Regulated Industries division is focused on developing translation and content management solutions tailored to address the complex regulatory environment in force with premium sectors such as Life Sciences and Healthcare (medical and in-vitro device, pharmaceuticals, CROs, healthcare companies), Finance (banks, asset management companies, insurance providers, fintech) and Legal (law firms, audit companies).

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Network Partners is a professional services company delivering tangible results by providing life sciences leaders with the right combination of strategy and professional implementation to move their programs forward. We support life science companies in the areas of Regulatory Affairs, Quality, Packaging Engineering, Labeling, and Project Management. Our team of professionals is led by industry-recognized subject matter experts and supported by The Knowledge Bench™. This collection of information and collaboration keeps our growth mindset team on the cutting edge of industry knowledge and professional development.

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Acolad is a dynamic and passionate leader in the global content space providing a full suite of content and language solutions, services and technology. With content at our core, we address all content-related needs: from digitalization to globalization. For decades, we’ve been committed to helping customers across key industries engage with their markets, increase revenue, and drive process efficiencies through cutting-edge content solutions and technology.

Partnering with medical device, pharmaceutical, biotech and clinical research organizations, Acolad Life Sciences provides the highest level of language and content services, unmatched expertise, and industry knowledge that helps save lives.

Visit Sponsor Website

At Veranex, we can help you with concept through to commercialization by enabling:
• Accelerated speed to market
• Controlled development costs
• Development risk mitigation
• Market viability assessment

At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions.

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Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. 25 years later, we are proud to have helped hundreds of clients complete their projects and thousands of consultants find great assignments. We continue to focus on helping our clients and consultants as well as our community as a certified women-owned, award-winning staffing company that works exclusively with Learning & Development professionals to match consultants to client projects.

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TELCOR is the proven leader of health care software solutions for revenue cycle management (RCM) software and services designed specifically for laboratories. TELCOR RCM, our SaaS solution, and TELCOR Revenue Cycle Services, our billing service, are designed to streamline workflow, improve collections, and provide real-time analytics. Our software and service solutions are designed for the unique challenges and requirements of laboratory specialties and the clients they serve. With full access to data, labs have complete visibility of their data and can track key performance indicators. No other vendor works as hard ensuring you get paid for the work you do.

Visit Sponsor Website

At Tipping Point Media, we pride ourselves on developing innovative, creative, and technically advanced virtual training and digital marketing solutions for the life sciences industry.

We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates.

Our dedicated team of educators, medical experts, certified programmers, and digital renaissance innovators are committed to creating high-quality custom creations that bring your company's vision to life.

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VantagePoint Performance trains Salespeople to be more fluent and comfortable across different situations needing different sales approaches, and we train Sales Managers to be better coaches and team leaders, with more focus and less stress.

We’re different from the average sales training company because:

We don’t believe that one approach, one system, or one methodology is absolutely superior. All have something to offer, and the “best approach” or “best system” depends on the sales situation. This is what our applied, academic research tells us.
Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. We provide insights from each client’s data to help them understand what drives the success of their top-performing Salespeople and Sales Managers.
We are constantly feeding what we learn back into our training products, and we invest a bigger slice of our total energy into this innovation than the average sales training company. Our clients can access always-refreshed intellectual property and content through our training subscriptions.

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Policy Reporter, acquired by TrialCard in 2019, provides innovative healthcare software solutions to track payer policies in near real-time and enhances market access for the therapies patients need most. The company’s patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. Its clients include some of the world’s largest pharmaceutical and healthcare companies.

Visit Sponsor Website

13th Annual

Medical Device & Diagnostic Labeling Professional Education Course

September 19-20, 2023 | Virtual Event

Enabling Efficient Methods to Remain Abreast of Continuously Evolving International Requirements & Swiftly Integrate New Provisions with an Ongoing Focus on Europe, all while Optimizing Localization Strategies & Enhancing Processes via Enterprise Labeling Systems

Program Overview

Countdown to the Medical Device & Diagnostic Labeling Professional Education Course

Experience the Quality First Difference.

Learn from Industry Leaders

Keep up with Industry Trends

Exchange Ideas & Network

Find Solutions that Work for You

“It was a fun to be part of a well-organized event and in the company of knowledgeable industry professionals, thanks again!”

Andrew Surprenant, International QA Compliance Manager, Instrumentation Laboratory

Distinguished Presenters Include:

Jane Li IVD Product Reviewer GMED NORTH AMERICA

Adam True Lead Auditor, MHS TÜV SÜD

Irene Hsieh Sr. Director of Regulatory Affairs & Clinical Affairs EUROIMMUN

Roger Peterson Senior Manager, Global Labeling, Regulatory ARTHREX

Join our LinkedIn Group to stay up-to-date on all things Medical Device Labeling

The Q1 Productions Virtual Event Experience

Are You a Solution Provider?

Reach out to us here.

Our Sponsors

“Excellent meeting with good speakers and brilliant discussions. Liked the interactive atmosphere and the opportunities to discuss with peers how they prepare for the new legislation. The meeting was ran very professionally.”

Attendees by Job Title

Director

Manager

Other

Attendees by Company Size

More than 10k

1k - 10k

Less than 10k

Attendees by Years of Experience

20+ Years

15-20 Years

10-15 Years

Less than 10 Years

Attendees by Industry:

Medical Device

Diagnostic

Other

Reach out to us with any questions.

Our team will respond promptly!

Chris Cockerell Senior Event Manager Q1 Productions +1 (312) 224-8722 ccockerell@q1productions.com

Jane Li
IVD Product Reviewer
GMED NORTH AMERICA

Adam True
Lead Auditor, MHS
TÜV SÜD

Irene Hsieh
Sr. Director of Regulatory Affairs & Clinical Affairs
EUROIMMUN

Roger Peterson
Senior Manager, Global Labeling, Regulatory
ARTHREX

Chris Cockerell
Senior Event Manager
Q1 Productions
+1 (312) 224-8722
ccockerell@q1productions.com