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UDI Consulting

Unique Device Identification (UDI) requirements for medical devices are currently being implemented by Health Authorities like FDA, EU (under new MDR), MHRA, China, Singapore and other countries making Unique Device Identifier (UDI) mark mandatory on labels and packages of most medical devices and other global health authorities are expected to adopt similar programs in the coming years. To be UDI compliant, regulatory data management and on-time submission is necessary.

In order to establish compliance you need to follow the following steps:

  1. Appoint someone who would work as a contact between you and the authority.
  2. You need to have separate UDIs for each of your product.
  3. Know your Global Medical Device Nomenclature (GMDN) code or CND (for EU)
  4. Submission of Device Information.

Our Role

Your regulatory team can manage all the compliance related aspects with our regular assistance. In addition, we provide some other services like:

  • Bullet Gap assessments for UDI compliance
  • Bullet UDI readiness assessment
  • Bullet Complete data analysis and management (collection, collation, validation and implementation)
  • Bullet Helps you implement UDI processes compliant with latest regulations into your quality management system and operations
  • Bullet Develop road map identifying right accredited UDI agencies
  • Bullet Compliance assurance for both new or existing products placed
  • Bullet Provide support on supply chain process and validation to support UDI implementation

Why MakroCare?

Our expert team has 10+ years of experience in UDI to offer training and assist your teams. Whether you are beginner or bringing a new product to the market, entering new market or reinforcing compliance on current products in your portfolio, we help you build a plan that ensures timelines are met by speeding up the process, and your resources are not exhausted.

  • Bullet You get UDI regulations from all the health authorities at one place
  • Bullet Support for current and future submissions with end to end life-cycle maintenance
  • Bullet Apt analysis and suggestion based on your established process
The First Step

Let's talk about how MakroCare can help you