Comprehensive UDI Consulting Solutions
With the support of Celegence, your organization will be able to maintain compliance through a single, all-encompassing UDI system, as required in recent regulations of the MDR. Our comprehensive solution allows us to manage your medical device product data and distribute it seamlessly to regulatory authorities. Our technology will enable us to provide you with timely and cost efficient support to comply with changing data requirements from around the globe. Additionally, our team will help device companies collect and validate their UDI data, build UDI records in HL7 Structured Product Labeling format, submit electronically to the FDA’s Global Unique Device Identifier database and perform ongoing record lifecycle management.
Thorough UDI compliance ranges from the inclusion of GS1, HIBCC, or ICCBBA compliant barcodes and other mandatory information within a label or direct mark to the management and submission of regulatory data (primarily attribute information) to the relevant agency based on the intended device distribution. As agencies besides the US-FDA start implementing these requirements, rudimentary tools like Microsoft Excel will no longer be sufficient as a way to manage and maintain this compliance data.
With our assistance, your internal regulatory team will be able to maintain compliance with all aspects of your regional requirements. With our initial analysis, we can assess your organization’s current readiness in terms of data, processes, and systems to be compliant with new regulations such as EU MDR and UDI. Further, our expert team will be able to provide guidance relevant to your specific UDI issuing agency.
Our team has combined decades of UDI experience to be able to offer training and oversight to your staff. Whether you are bringing a new product to the market, or reassuring compliance on existing products in your portfolio, we can help you build a plan that ensures timelines are met, and your resources are not exhausted.
Our UDI Compliance Services:
Gap assessments for UDI compliance, looking at your device and label
UDI training and project management: starting with a workshop, we will help your staff get up to speed on the required process, documentation, and technology changes
Help you implement UDI processes into your quality management system and production operations
Identifying the right accredited UDI agencies
Ensuring UDI data is formatted correctly for submitting to GUDID and later, EUDAMED
Guidance on supply chain management and validation to support UDI implementation
Maintain your data related to UDI in the future
If your Regulatory Affairs team needs assistance on maintaining UDI compliance of a current device, or are looking to implement a UDI system for a new device, our expert team is here to help, fill the form below and one of our team members will get back in touch with you.