Two of the top three causes for Medical Device recalls is mislabeling and misbranding. In addition, 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 labeling and supplemented patient information documentation complies with the current product standards prevalent in the target country. It is also necessary for the organizations to adopt practices that enable them to react quickly in response to change in regulations, process and product specific requirements.
Freyr with a pool of Medical Device experts is ideally positioned to assist Medical Device companies in achieving compliance with quality. Freyr can offer end-to-end labeling services that span across updating, reviewing, analyzing, tracking and maintaining label changes in the entire life cycle of the device value chain providing labeling solution, right from device ideation to final artwork publishing.
- Create, update and review contraindications, warnings, precautions, Instructions For Use (IFU)
- Review of The applicable Medical Device symbols as per The product technical description and information
- Quality check of submission and commercial artworks
- Gap Analysis between distributed labels & submitted labels
- Tracking and maintaining label changes
- Compliance with the labelling standards across the globe with the current product standards prevalent in each country distributing their devices
- UDI and EUDAMED compliance
- EU MDR labelling compliance
- Trained dedicated teams experienced in developing clinical, safety, Regulatory, and scientific communication materials across the device life cycle
- Expertise in successfully handling global and regional Medical Device labeling for clients across the globe
- Global Regulatory expertise in covering Medical Devices, IVDs and Digital health devices manufacturersHighly qualified medical writers possessing extensive Regulatory Labeling experience
- In-depth and updated understanding of the global device labeling changes from multiple Health Authorities such as: USFDA, EMA, TGA etc.Dedicated compliance team tracking the status of core and company core data sheet (CDS / CCDS) implementation in regional labels
- Ability to provide 24×7 support by working across time zones for seamless support