UDI Audits

Ensuring Effectiveness and Scalability of Your UDI Program

Problem:

  • Most UDI programs were implemented quickly to meet US FDA timelines across a wide array of operational areas
  • Little time was available to optimize operations, ensure future scalability for additional regulations, or identify areas to capture business value and returns on investment
  • The next wave of UDI regulations are on the horizon, so now is the perfect time to right-size the UDI program to ensure your company is poised to handle new requirements in an efficient, scalable manner

Solution:

Our audit solution provides insights into your UDI program to confirm that compliance has been achieved, and more importantly to assess areas for operational improvements. Our audit team reviews all aspects of UDI, including labeling, direct marking, data attributes, transmission to the government databases, 3rd party supplier compliance, Implant Point of Use, Service and Repair items, and Accessories/Components to name just a few of the many areas involved.

USDM retains the leading experts in UDI and brings decades of experience to your company. We have deep experience in all areas of medical device operations, including Supply Chain, Manufacturing, Labeling, Regulatory Affairs, Quality, and Distribution. We provide business insights to make the most of your UDI investments and identify ways to drive business value and returns on investment to offset these compliance-driven costs. Finally, we make recommendations on more efficient and effective approaches to ensure that as the UDI regulations come into force you are prepared to address this growing workload with a minimum of staffing increases.

Why does this matter? You invested a lot of time and resources to become UDI compliant. Now is the time to make the most of these investments and prepare your company for the coming challenges of many global UDI initiatives.

How do we do this? Our experts are deeply involved with the evolution of the global regulations, and can provide you with the necessary insights to ensure your program is up to the challenges you will soon face. We are system-agnostic, and work within your current or planned framework to address these new needs.

One key focus area is the collection of the necessary attribute data to populate the data model. In our experience, up to 80% of the necessary data is not available in an electronic system or is not trustworthy, and must be manually captured, cleansed/enriched, reviewed, approved, and loaded. We are familiar with the processes needed to effectively capture and enrich necessary data and can significantly speed-up this activity. A key goal is to maximize data maintenance productivity to ensure the growth of resources is far below the growth of data points managed. Some of the key areas involved in this audit process are highlighted below.

Current UDI Compliance Posture
We review key aspects of UDI compliance with a focus on areas that contribute to scalability.

Product List
Based on our extensive experience with UDI, we help you understand the upcoming regulations and work with your teams to finalize the affected product list, with a particular emphasis on products that are subject to the various exceptions or are difficult to classify.

Labels
Label revision is a complex and time-consuming process. USDM will review your current process and make recommendations on ways to simplify and streamline to improve cycle time and cost. We will also review barcode and label printing solutions and barcode verification equipment and processes, and make recommendations on ways to improve these processes. We have deep experience in navigating the complexities of Direct Marking of instruments and implants to achieve compliance with UDI and Implant Point of Use needs and will bring insights into this evolving area to ensure compliance and optimize operations.

Data Collection, Storage, and Management
Working with your key internal and external stakeholders, we assess your current product master data systems, responsible organizations, and their governance and maintenance processes. We can help you define the needed current and future attributes to meet regulatory and business needs, and outline the gaps in your current data. We will review your processes for data collection, enrichment, reviews and approval, and loads for improvement ideas.

Transmission of Data to Government Databases
We will review your SOP’s or Work Instructions, your current method of loading GUDID, and make recommendations on how this process can be improved.

3rd Party Suppliers
USDM will review your 3rd party supplier compliance program to determine areas for improvement.

Business Process Optimization for Related Areas
There are a number of other areas affected by UDI regulations and processes were deployed or changed in those operations to assure compliance. USDM will use its extensive industry knowledge to review operational performance in those affected areas, such as Supply Chain, Distribution, Manufacturing, Regulatory Affairs, and Quality Assurance, and make recommendations on improvement areas.

Pictorial Representation:

USDM UDI Audit Solution

UDI Audits Key Audit Areas
UDI Audits Related Business Operations

UDI Audits Single Source of Truth

 Engaging with the industry-leading UDI experts at USDM provides you peace of mind that your UDI program meets current and future requirements and assures compliance in the most efficient manner possible.

We bring the following key differentiators to every UDI engagement:

  • The most talented group of UDI experts available in the industry
  • Extensive experience working with over 50 current and former UDI clients
  • Every USDM client has met their required UDI requirements on-time
  • A set of pre-configured solutions covering processes/procedures, data models, and best-in-class software solutions, or we can use these tools to quickly update your existing processes and systems

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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