Reed Tech SingleSource™ for Medical Devices

MedTech Regulatory Compliance

We help companies develop, implement and remediate UDI compliance systems

How can Reed Tech help?

We serve almost half of world’s top thirty medical device manufacturers with solutions and services tailored to the niche needs of medical device compliance for Unique Device Identification (UDI). We have expanded our offerings to include a variety of specialized compliance tasks. With dedicated regulatory professionals guiding your team on new or nuanced health authority regulations, Reed Tech can help you implement cost-effective strategies to accomplish compliance obligations.

Often, regulatory enforcement actions are due to a breakdown in compliance systems, where the right resources or limited or a quality culture reinforcement is needed. MedTech Regulatory Compliance from Reed Tech is here to help.

Predictable Budgeting

Ongoing Expert Access

Comprehensive Service Range

What regulatory help should your team be considering?

An experienced UDI-focused collaboration with Reed Tech creates an extension of your team. Our experts monitor new and updated health authority regulations and requirements, allowing your team to focus on other priorities. Device classifications, implementing specific regulations for EU EUDAMED or other health authorities, determining label requirements and help with gap analysis are just a few of the ways a regulatory compliance advisor like Reed Tech benefits your strategy.

Gain peace of mind with MedTech Regulatory Compliance covering all the health authority markets your products are sold in and customized for your scenario.

Service Level options are available for Basic, Advanced and Strategic to align with your specific needs. Review the service options for the best fit.  

 

  • General UDI and Device Registration
  • Data Management
  • Custom Business Analytic Reporting
  • API Integration
  • UDI Compliance Training
  • Regulatory Compliance Advisory Services
  • US Agent Services
  • Gap assessment and compliance risk assessment
  • Global UDI support
  • Address data element and other nuances for submissions to US FDA, EU EUDAMED, South Korea IMDIS, China NMPA, AusUDID and others
  • Strategic road map to address UDI system elements across organization, process and technology
  • EU EUDAMED development roadmap for electronic submissions where possible: Vigilance module, other
  • Consultation on responses to health authority or internally identified UDI system issues

Service Level Options

Additional MedTech Compliance Services

Find answers to your queries about our life sciences products right here.

What is included with UDI Channels launch?

UDI Channel Launch is an optional, one-time cost during the 1st year of channel implementation. Our experts will help with a detailed UDI attribute gap analysis, review of new channel business rules, dedicated support during health authority system integration and provide technical support along with regulatory compliance guidance where needed. 

What is the Data Analytics Report?

This is an optional, one-time cost for Reed Tech subject-matter experts to develop a tailored dashboard analysis of your UDI data. 

Options for Software Customization Service with SingleSource™

We will collaborate closely with your organization to tailor our UDI software to your specific needs, ensuring a fit for your processes and compliance goals. This is an optional, one-time cost for the initial custom feature development and annual maintenance cost.

Are there API Integration options with SingleSource™?

Yes, our UDI API Integration Services include designing, building and implementing custom middleware tailored to address unique integration needs. We specialize in middleware development and deployment with secure scalable technologies and can deploy within your IT infrastructure or cloud environment for efficient data exchange.

This is an optional, one-time cost for initial development and maintenance.

Do you offer Data Collection and Data Migration services?

Yes, we can assist and guide your team through a comprehensive plan to cleanse, transform and repurpose UDI data to meet the requirements of each health authority. 

Optional, as requested. 

How do I start a project plan or place an order?

Our expanded Regulatory Advisory Team can assist you with a wide variety of tasks and topics. Click on the Inquire Now button above or Choose Plan and fill out a few brief comments about your needs in order to facilitate an appointment. We look forward to learning more about how we can assist you.

See a world-view of Global Health Authority requirements