As a medical device manufacturer distributing your life-saving products overseas, you must be equipped to meet the many different labeling requirements in the countries you plan to participate in. With every labeling request comes unforeseen challenges, which means it never hurts to revisit medical device label requirements with each new request. From regulatory requirements being altered and variable implementation dates to process roadblocks, you may feel you are off the right track.
Understanding how a prioritized process, how you can meet basic labeling requirements, and plan for new conditions like translation will be influential in keeping your labeling request on time and on budget while ensuring compliance.
When a medical device is introduced to a new market, all labeling content is carefully reviewed for compliance with local rules and regulations. Any issues with the appearance or wording of your label can delay distribution, get a product recalled or potentially cause adverse events with patients. That is why it is critical that all documents – add their translation – are as accurate as possible from the beginning. Meaning your process must be in place at the beginning establishing responsible parties’ roles and how to accomplish compliant labeling.
Answering your Medical Device Label Requirements Questions
We know that the challenges you face in medical device labeling means you have new questions that come up with every request. So, we created a webinar in partnership with Heather Valley the Senior Director of Regulatory Affairs at Network Partners, a professional services firm that helps clients complete the work necessary to provide their products to patients. Serving the medical device, pharmaceutical and biopharmaceutical industries with core competencies in Regulatory Affairs, CER, Packaging Engineering, Labeling, Quality and Project Management.
With our webinar you will learn about medical device label requirements and preparing for submission, in just under an hour Heather and Morningside’s Life Science Translation expert Anna Eisenberg cover:
- how to prioritize your process
- create accountability
- plan for translations
- technology and best practices
- basics of regulatory requirements
- live Q&A
Our goal is to help ensure you save time and meet compliance, save money, and build and sustain your organization’s reputation. If you are ready, you can download our webinar now, “The Challenges & Changes in Regulatory Medical Device Labeling”.
Process Prioritization
Not knowing how to prioritize your process and neglecting your internal process is how medical device organizations often risk losing money, extending timelines, and in the worse case, hurting the organization’s reputation.
When you download our webinar, you will discover the benefits of planning early and involving your stakeholders in ownership, accountability, and planning through execution and discover how you can eliminate silos. Taking the time to prioritize your process helps to ensure each step is completed properly. Heather discusses what a “good” labeling process looks like and all the benefits you can gain from implementing practical and effective steps.
Medical Device Label Regulatory Requirements
Gain an understanding of what types of product literature fall under labeling. Learn about how symbology is used, such as standards, symbols, and even size and color. Take a look with us as we dive into what Unique Device Identifiers are, what goes into them, and how they are read. Then finally, we’ll explore e-labels and the challenges you can expect to face when using them.
Translating Labels
Translating medical device labeling is either an absolute requirement to sell your product in a specific region or a critical step in minimizing risk and liability. Given the nature of the content, medical translations shouldn’t be done by just anyone. These documents are highly technical and require scientific knowledge and expertise that even most gifted translators don’t possess.
Translating labels requires a unique specialization and an experienced language services provider (LSP) in the subject matter and specific therapeutic area. There is zero tolerance for errors because they can present a potential patient hazard. It is imperative to take great care when writing, translating, and submitting translated medical device labels or other localized medical documentation.
Anna Eisenberg is an Associate Director of Life Science Business Development at Morningside, with 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for the company’s life science strategy and maintaining relationships with global leaders in the field. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines. She will cover the lasting benefits of working with an experienced life science LSP that will help increase security, organize workflow, save time in compliance, and reduces costs.
Discover the advantages of working with an LSP specializing in regulatory submissions, packaging, labels, IFUs, manuals, and software. As well as one that has experience working with regulatory bodies around the globe and the tools needed to let you meet compliance.
Download our webinar, “The Challenges & Changes in Regulatory Medical Device Labeling”. Not only will this webinar help you save time, but you will help ensure compliance in your organization and build your reputation. You won’t want to miss out on this critical presentation for the medical device industry.
About Morningside
Morningside, a Questel Company equips the world’s leading life sciences organizations with a full suite of end-to-end language solutions for their regulatory, clinical, commercial and patent needs. With over 4,000 clients in 55 countries, we’re globally recognized for our life science expertise and technology innovation across pharma, biotech, medical devices, and healthcare. Our life sciences translation services ensure your products and ideas seamlessly reach new markets and comply with all regulatory and cultural requirements through every stage of the product lifecycle — from patent to post-market.
Madeline Sturdivant, Brand Marketing Manager at Morningside, a Questel Company, is an experienced marketing professional with five years in multiple disciplines, including digital, print, event, and strategy. She is responsible for the company's global marketing activities and managing relationships with the world's largest and most demanding healthcare, legal, and corporate organizations. Madeline's varied personal and professional interests drive her to continually expand her knowledge to benefit those around her.