meddevo eNB
Full Digital Certification for Medical Devices and IVDs
Our team is researching to streamline the entire conformity assessment process for Notified Bodies. Exclusively designed for Notified Bodies with digital capabilities of our time.
100% Digital Submission
Digital submission from manufacturer to Notified Body
Content & Document Based
Support for both content-based and document-based workflows
Automated Pre-Assessment
Streamlined pre-assessment to accelerate the review process
Digital eNB
It's time to not only rethink the incredibly labor-intensive certification process, but to redesign it. With all the digital capabilities of our time.
With meddevo eNB our team is researching to streamline the entire process for Notified Bodies. Manufacturers can participate in the process with or without digital documentation for their devices.
- 100% digital submission from manufacturer to Notified Body
- Content based and document based workflows
- Automated pre-assessment for faster reviews
Accelerating the Certification Process
We are currently researching and developing the interfaces between Notified Bodies and digital documentation. Notified Bodies can also process customers who maintain classic PDF/Word/Excel-based documentation.
However, they can already work with pre-assessments in the process, significantly reducing time-to-market for medical device certifications.
The Importance of Digital Solutions in Accelerating Notified Body Conformity Assessment Processes
In the field of medical devices and in vitro diagnostics (IVDs), conformity assessment processes play a key role in ensuring that products meet stringent safety and performance standards. These processes, performed by Notified Bodies, are critical to maintaining the integrity of the healthcare industry.
The Digital Shift
Digital solutions, such as meddevo's eNB, streamline the entire process for Notified Bodies. They enable 100% digital submissions from manufacturers to Notified Bodies, facilitating both content-based and document-based workflows.
This digital approach eliminates the need for manual data entry, reducing the risk of errors and ensuring the accuracy of information. Automated pre-assessments further increase efficiency by providing an initial review of the documentation.
Increased Efficiency
Automated pre-assessments identify potential issues that may hinder the conformity assessment process. This allows Notified Bodies to focus their efforts on areas that require their expertise, significantly reducing the time spent on each assessment.
Traditional methods can be labor-intensive, time-consuming, and prone to human error. As we move into the digital age, it is becoming increasingly clear that digital solutions are not only beneficial, but essential.
Complete Audit Trail & Version Control
Digital solutions provide a level of transparency and traceability not possible with traditional methods. Every action is logged and every document version is stored, providing a clear audit trail.
This not only aids the audit process, but also provides valuable insight for manufacturers to improve their processes and products.
Document submitted
Manufacturer A
Pre-assessment completed
System
Review started
Assessor
Comments added
Assessor
Revision requested
Lead Assessor
Please provide additional clinical data for Section 4.2
Updated documentation attached with additional clinical evidence
Seamless Collaboration Between All Parties
Digital platforms promote better collaboration and communication between manufacturers and Notified Bodies. They provide a centralized location for all documentation, making it easier for all parties to access and review the necessary information.
This collaborative approach allows for a more seamless and efficient assessment process, reducing back-and-forth communication and accelerating time-to-certification.
Built for Modern Notified Bodies
A comprehensive digital platform designed specifically for the conformity assessment process
Digital Submissions
Accept 100% digital submissions from manufacturers with support for all document formats.
Automated Pre-Assessment
AI-powered initial review to identify potential issues and streamline the assessment process.
Complete Audit Trail
Every action logged with full version control for complete transparency and compliance.
Team Collaboration
Built-in communication tools for seamless collaboration between assessors and manufacturers.
Multi-Regulation Support
Support for MDR, IVDR, and other regulatory frameworks in one unified platform.
Smart Search
Intelligent search across all documentation to quickly find relevant information.
Transforming Conformity Assessment
100%
Digital submission capability
80%+
Reduction in assessment time
Complete
Audit trail and traceability
A Leap Towards a More Efficient Future
As we look to the future, it's clear that digital solutions will play an increasingly important role in the conformity assessment process. Notified Bodies that embrace these solutions will be better equipped to meet the growing demand for medical device and IVD assessments.
The adoption of digital solutions by Notified Bodies is not just a step towards modernization; it's a leap towards a more efficient, accurate and transparent future.
As we continue to innovate and evolve, we must embrace these digital tools that not only enhance our capabilities, but also ensure the safety and efficacy of medical devices and IVDs.
meddevo eNB Edition is the starting point for a full digital conformity assessment. Want to learn more? Talk to our team.
Improved Patient Safety
Faster certification means safe devices reach patients sooner
Better Healthcare Outcomes
Streamlined processes contribute to overall healthcare improvement
Industry Modernization
Leading the digital transformation of regulatory compliance
Join the Digital Transformation
Are you a Notified Body interested in digital conformity assessment? Be part of shaping the future of medical device certification.
Contact us to learn about eNB research
Discuss your Notified Body requirements
Get early access to the platform
Shape the future of digital certification
Ready to digitalize conformity assessment?
meddevo eNB is researching the future of digital certification for Notified Bodies.
Exclusively for Notified Bodies. Be part of the transformation.
No credit card required. Contact us to learn more.