Medical device manufacturers face an array of challenges in delivering their products to domestic and international markets. With potential risks to patient safety, Regulatory review, and ultimately brand equity, organizations must ensure that medical device labeling documentation complies with the current medical device labeling standards prevalent in each country where the device is distributed. It is also necessary for these organizations to adopt practices that enable them to react quickly to process change in medical device labeling requirements.
For medical device manufacturers, the definition of medical device labeling includes any type of packaging or device identification, as well as anything that describes the device, its capabilities, and its intended use. This varied definition multiplies the challenge usually faced while attempting to meet international Regulatory compliance. While identifying medical device labeling requirements and other international safety standards assist in tracking devices through the global supply chain, a variety of such standards in use today only complicate harmonization efforts further. For device manufacturers, the supply chain can include contract manufacturers, private label and re-label partners, distribution points, and point-of-use healthcare providers.
With a comprehensive knowledge of global medical device markets, Freyr offers end-to-end medical device labeling services that span across updating, reviewing, analyzing, tracking, and maintaining medical device labeling changes.
- Create, update & review contraindications, warnings, precautions
- Create, update & review Instructions for Use (IFUs), patient information / patient guides, treatment guides, user manuals, maintenance manuals and other types of labeling components
- Quality check of submission and commercial artworks
- Gap analysis between distributed labels & submitted labels
- Tracking global medical device and EU MDR labeling requirements and changes
- Symbology management
- Resources with in-depth Regulatory knowledge
- Expertise in successfully handling global and regional device labeling for Fortune medical device clients worldwide
- Extensive global experience in covering diverse Regulatory domains across device industry
- Highly qualified medical writers possessing proven Regulatory experience
- In-depth and updated understanding of the global medical device labeling changes as required by local Regulatory bodies
- Dedicated compliance team tracking the status of data sheets implementation in regional labels
- Highly experienced labeling professionals
- Extensive labeling project delivery experience complying with the FDA and EU medical device labeling requirements
To streamline end-to-end Regulatory labeling practice from creation to tracking to managing in company of any size, Freyr offers a centralized labeling life cycle management software, Freyr LABEL. Right from creating, tracking and managing company core data sheet (CCDS) deviations, CCDS updates, and developments to creating, implementing, and inspecting multi-lingual regional labels as well as custom reporting. Freyr LABEL puts companies in total control of all their Regulatory labeling compliance needs.
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