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 are 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
- Dedicated UDI Project Lead
- Up to 1,000 Products
- 1 Channel
- Up to 50 Hours of Training and Support
- Quarterly UDI Status and Alignment Meetings
- Up to 10 Hours of Global Regulatory Advisory and Market Access Support
- Dedicated UDI Project Lead
- Up to 10,000 Products
- Up to 3 Channels
- Up to 100 Hours of Training and Support
- Monthly UDI Status and Alignment Meetings
- Up to 20 Hours of Global Regulatory Advisory and Market Access Support
- Dedicated UDI Project Lead
- Over 10,000 Products
- Greater than 3 Channels
- Up to 200 Hours of Training and Support
- Bi-Weekly UDI Status and Alignment Meetings
- Up to 30 Hours of Global Regulatory Advisory and Market Access Support
Additional MedTech Compliance Services
Find answers to your queries about our life sciences products right here.