Industry
Solutions for Medical Device Manufacturers
Achieve modern compliance, operational efficiency, and life-changing innovation with solutions exclusively for the medical device industry.
From design and development to post-market surveillance, a seemingly small process deviation or change to a component can affect product quality and patient safety. You may also suffer data loss and possible regulatory actions or recalls.
The Medical Devices team at USDM Life Sciences helps customers bring their products to market faster, monitor their products in the field, and handle post-market surveillance. All this while addressing a variety of regulatory challenges that are unique to the medical device industry.
Whether you are a large global medical device manufacturer or a small startup, USDM can help define and develop a top-to-bottom risk management strategy to ensure resources are aligned, profitability is maximized, and regulatory compliance is achieved and maintained.
USDM offers comprehensive services to help navigate a complex regulatory landscape, including compliance and quality strategies, audits and assessments, remediation, validation and qualification, and global product identification.
Next-Generation Solutions for Medical Device Manufacturers
As an industry leader, USDM has the right regulatory compliance solutions for your organization to maintain audit readiness or remediate quality processes. Learn how a large medical device manufacturer upgraded its quality system and recertified existing devices for European Union (EU) Medical Device Regulation (MDR) requirements—in less than eight months.
Data Strategy & GxP Technologies for the Future
Life science organizations want to use cloud technologies to eliminate costly on-premises solutions that no longer meet their business needs. See how a global medical device company addressed FDA audit findings for nearly 2,000 GxP software applications. USDM conducted an assessment and reduced the number of systems by more than 80%.
Optimize Your Data for AI Readiness
Improve data quality, governance, and compliance with comprehensive data management and data science solutions that capitalize on advanced analytics, AI, and machine learning. Our AI experts help your organization derive actionable insights, streamline operations, and enhance decision-making while ensuring data integrity and adherence to regulatory standards like GDPR and CCPA.
Intelligent Workflow Automation
Streamline and optimize business processes through technology to help your organization improve operational efficiency. We drive transformation by rethinking workflows, leveraging AI-driven automation, and integrating advanced digital tools to generate value, underpin scalability, and nurture operational excellence.
UDI Strategy and Implementation
Trust USDM to help your medical device company accurately submit Unique Device Identification (UDI) data to the European Databank on Medical Devices (EUDAMED) and other regulatory agencies. Our services include a complete assessment of supply chain and regulatory activities, a total inventory of medical devices, and comprehensive plans for process improvement and overall readiness.
Expertise in Action
Watch these short clips where industry experts discuss the global UDI landscape.
Indira Konduri from the FDA’s Center for Devices and Radiological Health (CDRH) discuss UDI in recalls.
Lionel Tussau, Healthcare Global Lead at atrify, discuss UDI triggers.
Watch the full-length on-demand webinar UDI Beyond Borders.
Next-Generation Solutions for Medical Device Manufacturers
Unlike typical consulting companies, USDM doesn’t just provide recommendations—we become a partner in your journey to digital transformation. Our strength lies in our unique blend of regulatory expertise, cutting-edge technology integration, and an adaptive approach customized to your organization’s needs. With over 20 years exclusively focused on the life sciences sector, we understand the complex challenges of pharmaceutical compliance and leverage our regulatory partnerships with agencies like the FDA and EMA to provide proactive, compliant solutions.
Why USDM for Medical Device Organizations:
- Life Sciences Expertise: 20+ years in life sciences, specializing in medical device manufacturers.
- Proven Track Record: Thousands of GxP projects completed globally, tailored for medical devices.
- Industry Trust: Trusted by over 900 customers, including top and emerging medical device companies.
- Compliance Solutions: Innovative cloud compliance and GxP automation solutions to enhance efficiency.
- Cloud Assurance: Ensures compliance, audit readiness, and risk management for medical devices.
- Technology Partnerships: Collaborations with top providers to deliver GxP-ready functionality.
- Digital Transformation: Support for integrating technology, people, and processes for maximum ROI.
- Flexible Engagement: Managed services, consulting, and staff augmentation to fit unique needs.
Frequently Asked Questions
Changes requiring a new UDI are primarily related to identification and differentiation of a specific device and the stakeholder’s needs and ability to differentiate devices.
For example, devices manufactured on different lines typically have a different lot number. For a device that can be managed through other identifiers like lot number or manufacturing date, there is no need to differentiate a device identifier (DI).
Your first action should be to understand all of the requirements and how they apply to your devices. Next, you’ll want to identify gaps and determine a path to remediation. Then you need to decide whether you can or should produce market-specific versions. More importantly, implement robust internal processes to account for new requirements and changes in existing products or to their attributes.
Ready to transform your data management strategy and GMP operations?
USDM Thought Leaders
