The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access. Organizations must ensure that labeling documentation and artwork designs that they produce comply with the global/regional Regulatory standards as they cause potential risks to patient safety, Regulatory reviews and ultimately brand equity. Thus, they should adopt best practices not only to create compliant artworks, but also to respond and react quickly for necessary change requirements and amendments.
Freyr with its pool of artwork design and labeling experts and with a specialized focus on medical devices is ideally positioned to offer labeling and artwork design solutions, right from ideation to final artwork publishing. Freyr offers end-to-end labeling and artwork services that span across creating artworks, updating labels, reviewing, analyzing, tracking, and maintaining the label changes. Freyr in-house design team is equipped with Researchers in packaging component, Design experts (Art Director, Designer), Copywriters, Technical Proof-readers, and Packaging Label Reviewer team, and Regulatory Affairs team.
- Create, update, and review contraindications, warnings, precautions, Instructions for Use (IFU)
- Review of the applicable medical device symbols as per the product technical description
- Artwork studio for medical devices along with artwork QC services
- Quality check of submission and commercial artworks
- Gap analysis between distributed labels & submitted labels
- Tracking and maintaining label changes
- Compliance with the global labeling standards and with the current product standards prevalent in each country where they are distributing their devices
- UDI and Medical Device Regulations (MDR) compliance
- One-stop shop for end-to-end Regulatory consultation for medical devices artwork
- Trained and experienced teams for developing clinical, safety, Regulatory, and scientific communication materials
- Coordinated teamwork and engagement by leveraging unified information management platforms
- Expertise in handling global and regional medical device labeling
- Global Regulatory expertise in covering medical devices, IVDs and digital health devices
- Highly qualified experts possessing extensive Regulatory labeling experience
- In-depth and updated understanding of the global drug 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