UDI Compliance

FDA-approved. EUDAMED-tested.
GAMP 5 validated ~ 21 CFR Part 11 compliant.

Global device manufacturers must often submit UDI data to a myriad of country-specific regulatory authorities, each with their unique data exchange standards and requirements.  Innovit’s UDI compliance solutions enable device manufacturers to implement a single data syndication system for global coverage.  Leveraging one solution to aggregate, validate and submit product data to regulatory agencies at the market-specific level around the globe.

FDA-approved for GUDID submissions.  GAMP 5 validated and 21 CFR Part 11 compliant ~ it’s tailored to meet the unique system validation requirements (SQA) of medical device and healthcare industries.

EUDAMED and China UDID testing ‘playgrounds’ coming soon!

Features & Benefits

Data Validation

Deliver trusted, high-quality product data by leveraging Innovit’s built-in data quality and data validation tools.
Ensure that product data is accurate and compliant with any pre-defined set of validation rules from regulatory agencies, as well as any internal, user-configured data attributes and validation rules.

GAMP 5 Validated

Innovit systems and processes are fully validated to comply with GAMP 5 standards software development, quality assurance, technical support, system implementation.
Built-in functionality for data versioning and electronic signatures to comply with 21 CFR Part 11 requirements (and EU Commission’s Annex 11).

M2M Data Submission

Proven machine-to-machine (M2M) capabilities for regulatory data submissions that ensures data accuracy and a scalable process for data compliance in all markets.
Ease of enabling new countries at a fraction of the cost of alternatives such as data submission services or standalone country-level compliance solutions.

Dedicated Customer Success Specialist

Vamshi is well known for building and sustaining strong client relationships. He leverages his diverse experience in Business Analytics and Quality Assurance to help all Innovit customers achieve success.
When Vamshi isn’t chasing after his five children, you will find him enjoying a good book.

Book a free Consultation