Life Sciences Expertise
Unique Device Identification and the European Union’s Medical Device Regulation
We discuss critical SaMD regulations and implications for your QMS and help you think through your approach to achieving a compliant IT development environment.
Managing quality through the supply chain with UDI
Be prepared for Unique Device Identification (UDI) requirements with USDM’s implementation and compliance solutions and expert guidance on global regulations. USDM Life Sciences is the industry leader in UDI regulatory compliance solutions for the medical device industry. We have well-established relationships with the most prominent IT vendors in the world, and an experienced team of subject matter experts led by Jay Crowley, who developed the framework and authored key requirements for the FDA’s UDI system. We can help your organization execute a program to support your UDI efforts.
Tailored to the UDI Final Rule in the United States and the UDI Regulation in the European Union (EU), our UDI guidance and implementation solutions can help you utilize the benefits of UDI while achieving regulatory compliance.
We offer our customers the following UDI guidance and services.
Global Readiness Services
- UDI Audits
- UDI Program Design and Execution
- UDI Product Analysis (class III, FDASIA, II, I)
- UDI Business Process Analysis and Improvement
- UDI Policy Development
- UDI Regulatory Guidance
Global Regulatory Database Submission Services and Support
- Submission Strategy
- Submission Preparation
- Submission Support
- UDI System Enhancements and Validation
- US UDI
- US UDI Class 1 Medical Device Compliance Toolkit
- European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Implementation and Compliance
- Saudi Arabia UDI Implementation
UDI Education and Training
- UDI Regulation Overview (e.g., US FDA UDI Final Rule, MDR/IVDR)
- UDI Regulatory Database Training
EU MDR and IVDR Compliance
Medical device manufacturers must comply with EU MDR by May 26, 2021, and IVDR by May 26, 2022.
USDM Life Sciences offers many solutions to help plan, execute, and manage any or all enterprise-wide activities necessary to meet the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.
USDM’s EU MDR and IVDR compliance solutions include:
- Gap assessment and product portfolio rationalization
- Economic Operator (EO), device registration, and UDI Database submissions
- Assess devices with valid MDD/AIMD certificates that will be distributed after 2020
- Assess devices that will be (re)certified to the EU MDR
- Assess Class I devices and systems and procedure packs that must be EU MDR compliant by 2020
- Assess EO, assess AR, importer, distributor compliance (enhanced responsibilities of other economic operators including traceability)
- Assess QMS (ISO 13485:2016 as standard), identifying additional SOPs or changes to existing SOPs required to manage EU MDR, including UDI
European Databank on Medical Devices (EUDAMED) Submission Solutions
USDM’s Organizational Readiness Assessment for EUDAMED includes:
- Complete assessment of supply chain and regulatory activities required to support the submission of data to EUDAMED
- Inventory of medical devices subject to EUDAMED regulatory requirements for further assessment
- Identify process improvements to support the submission of data to EUDAMED
- Assess the overall readiness of the organization to meet EU regulatory reporting requirements
USDM’s System Validation for EUDAMED includes:
- Conduct system validation activities required for EUDAMED submissions
- Identify any system integration issues and recommend corrective actions
- Identify process and documentation improvements necessary to meet EU regulatory requirements
- Deliver system validation activities and documentation for new or modified systems
USDM’s UDI Data Validation for EUDAMED includes:
- Conduct validation activities on the data required for EUDAMED submissions
- Identify any data integrity concerns that may delay EUDAMED that may delay EUDAMED submissions
- Assess areas for improvement to prepare for and expedite data submissions to EUDAMED
Still have UDI/MDR questions? Contact us today to talk with our SMEs.
USDM Cloud Assurance
USDM Cloud Assurance is a managed service that offloads your SaaS vendor management and maintenance of ongoing system updates, patches, and changes.
Your data is the lifeblood and most valuable asset in your organization. How you access it, store it, move it, and back up and archive it, is all part of your data integrity strategy.
GxP Managed Services
USDM’s managed services for life sciences are bundled into subscription models or offered at fixed fees to control your IT spending while maintaining compliance.