Medical Device Labeling Services and Technical Writing Support

Regulatory labeling stands as a key aspect of patient safety and product integrity. To secure both, manufacturers must prepare, compile, and submit their labels in an accurate and compliant way abiding by the region-specific regulatory labeling standards. Amidst rapidly evolving global regulatory standards and ever-changing regional regulatory frameworks for medical device labeling, device manufacturers need a trustworthy regulatory partner to prepare and oversee the technical documentation and submit it to health authorities.

At Vigilare, we offer end-to-end medical device labeling services and technical writing support to ensure MedTech organizations meet compliance expectations. It ranges from compliant UDI system integration to regional and local medical device labeling compliance.

Vigilare’s Medical Device Labeling Services and Technical Writing Support

Global UDI for Medical Device Labeling Compliance

Integrating Unique Device Identification (UDI) onto the device is no longer an option. It is a mandatory requirement to obtain medical device labeling compliance across the major regulated countries, including the US, Europe, China, and South Korea. At Vigilare, we help manufacturers to comply with UDI standards. We develop UDI strategies and validate them for compliance with FDA 21 CFR Part 830 and EU MDR standards.

In addition, we coordinate for submissions like GUDID (FDA) and EUDAMED (EU) along with maintaining data integrity throughout the device life cycle. We minimize the risk of recall and the chances of relabeling with meticulous UDI implementation, i.e., compliant and traceable.

Country-specific Labeling Requirements

While launching a product, manufacturers must recheck their product’s labeling information. They should verify whether it accurately reflects safety information, local device risk classifications, and compliance with regulatory declarations or not. Because every country has unique labeling requirements that go beyond language translations. At Vigilare, we assist device manufacturers with language localization and validation of label content with local regulatory frameworks, creation of technical documentation i.e., IFUs, Safety Sheets, Product Datasheets, etc., and formatting, and regulatory review of periodical updates.

Facts to Focus

Labels Processed

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Testimonials

Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.

We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.

Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.

We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.

Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.