MakroCare helps companies define Regulatory strategies for their medical devices and diagnostics right from the product development to life cycle management to address different pathways & submission requirements utilizing our global scientific, regulatory and technical experts.

You can leverage our experience of 20+ years gained from successful regulatory projects spanning 80+ countries. Our proprietary regulatory requirements database combined with regulatory experts provide customized experience.

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:

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

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

We’re here to help

Get in touch with us