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