Medical Devices Artwork Management: Overview
The current medical devices artwork management 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 medical device packaging artwork 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 artwork but also to respond and react quickly to 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 medical devices artwork services, including labeling and artwork design solutions, right from ideation to final artwork publishing. Freyr offers end-to-end labeling and medical device artwork services that span across creating artwork, updating labels, reviewing, analyzing, tracking, and maintaining label changes. Freyr’s in-house design team is equipped with Researchers in the packaging component, Design experts (Art Director & Designer), Copywriters, Technical proofreaders, a Packaging Label Reviewer team, and a Regulatory Affairs team.
Medical Devices Artwork Management – Freyr Expertise
- Create, update, and review contraindications, warnings, precautions, and 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 submissions and commercial artwork.
- 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.
Medical Devices Artwork Management – Freyr Advantages
- One-stop shop for end-to-end Regulatory consultation for medical devices artwork management and medical devices artwork services.
- Trained and experienced teams in 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, including medical device packaging services.
- 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.
- Expertise in medical device packaging validation and medical device packaging design.
- Specialized knowledge of the artwork development process and medical device packaging artwork.
- State-of-the-art medical device artwork studio facilities.
