OVERVIEW
Swissmedic has established swissdamed as Switzerland’s national database for managing medical device and economic operator information. Manufacturers placing products on the Swiss market are required to submit and maintain accurate device information in swissdamed in accordance with Swiss regulatory and technical requirements.
Innovit SWISSDAMED Connector simplifies the aggregation, management, validation, and machine-to-machine (M2M) submission of device data to swissdamed. Built specifically for regulated healthcare environments, it supports GAMP 5 system validation principles and addresses the requirements of 21 CFR Part 11 and EU Annex 11.
INNOVIT SWISSDAMED CONNECTOR
Innovit SWISSDAMED Connector provides a purpose-built solution for medical device manufacturers to manage, validate, and submit compliant UDI data to swissdamed. The solution includes a pre-configured swissdamed data model with the required data types, attributes, code lists, and validation rules, helping organizations efficiently prepare submission-ready device data while maintaining alignment with Swissmedic requirements.
The solution provides native machine-to-machine (M2M) connectivity to swissdamed, enabling secure electronic submission and ongoing maintenance of device information using the required REST APIs and XML formats specified by Swissmedic. Comprehensive audit trails, configurable approval workflows enabled with electronic signature, and complete message exchange history provide full visibility into data changes, approvals, submissions, and swissdamed responses.
As Swissmedic continues to evolve the swissdamed database, Innovit keeps the connector aligned with the latest technical specifications and regulatory requirements, helping customers reduce the effort of maintaining long-term compliance while supporting efficient regulatory operations.
BENEFITS
Accelerate swissdamed device submissions
Meet evolving Swissmedic UDI submission requirements through a purpose-built solution designed specifically for swissdamed.
Ensure data quality before submission
Validate device information using native swissdamed business rules to identify issues before submission and reduce errors.
Streamline data governance and approvals
Strengthen data integrity with configurable approval workflows, audit trails, electronic signatures, and complete submission history.
Reduce operational and IT cost
Eliminate custom integrations and manual effort with a purpose-built, M2M submission to swissdamed that lowers TCO.
Ensure compliance with quality & security standards
Meet regulatory requirements for system quality, security, and data integrity including 21 CFR Part 11, Annex 11 and GAMP 5 system validation standards.
Capability Highlights
Explore the core capabilities that enable efficient, reliable, and compliant device submissions to swissdamed.
| Category | Features |
|---|---|
| Data Import | Easily onboard device data from your ERP, PLM, PIM/MDM and other source applications |
| Data Maintenance | Out-of-the-box swissdamed data model with relevant data types, attributes, code lists and data validation rules Simplified data maintenance with configurable web forms and native bulk edit capability |
| Data Governance | Native swissdamed data validation rules Audit trail and complete version history of data changes Easy-to-configure approval gates enabled with eSignature Complete approval history Granular role-based security Data quality dashboard to track data validation and submission status for swissdamed |
| Data Submission | Native M2M connectivity to swissdamed Required REST API and swissdamed XML support Full visibility to swissdamed responses and submission status Message log for full message exchange history with swissdamed |
| Compliance | Swissmedic UDI requirements 21 CFR Part 11 and Annex 11 GAMP 5 System Validation ISO 27001, SOC 2 and other relevant information security standards Independent USDM audit proving compliance and GxP readiness |
“Innovit SWISSDAMED Connector streamlines Swiss UDI compliance through trusted device data management, native validation, and secure machine-to-machine submissions.”
Data Flow Models for swissdamed Submission
With Innovit SWISSDAMED Connector, customers can leverage pre-packaged and custom data flow models to support their internal business processes for aggregating, maintaining, validating and submitting their device data. The pre-packaged data flow models come in 2-Stage and 3-Stage variations, while also providing a Passthrough option for organizations who do not have users maintaining data in Innovit’s application.
2-Stage Data Flow Model
This model has two distinct stages: maintenance and submission. The maintenance stage comes pre-packaged with the swissdamed data types, attributes, code lists and data validation rules that customers need to manage and validate their device data. Once the data is validated and approved, it is released to the submission stage where users can submit their clean and validated data to swissdamed.
Best For:
Organizations maintaining device information directly within Innovit or importing data already aligned with the swissdamed format.
3-Stage Data Flow Model
This model has three distinct stages: aggregation, maintenance, and submission. The aggregation stage allows users to consolidate and cleanse raw device data from multiple source systems to create a complete device record. The data is then converted into the required swissdamed format in the maintenance stage and follows the standard data validation and submission process as the 2-stage model.
Best For:
Organizations with multiple source systems that need to aggregate, cleanse, and normalize device data before converting it into the swissdamed format.
Passthrough Data Flow Model
This model supports a fully automated flow where device data is maintained upstream and only passes through Innovit’s solution for data validation and submission. Device data is automatically imported, mapped and validated against swissdamed rules, and submitted without manual intervention. Data validation and submission reports are sent back to the source system, where any corrections are made and resubmitted.
Best For:
Organizations with upstream systems where users manage all device data and require a fully automated data validation and submission process.
User Configurable Workflow Model
This model leverages Innovit’s Collabri workflow engine to enable fully configurable, advanced workflow orchestration. Users can design custom data flows with multiple stages, dynamic routing, and role-based tasks using a visual interface. It supports complex approval processes, conditional logic, escalation policies and automated task management to handle sophisticated data management and governance requirements.
Best For:
Organizations with advanced governance, approval, or regulatory review processes requiring configurable workflow orchestration.
Hosting
Different hosting options are available for customers.
Multi-Tenanted
Public Cloud
Shared environment with shared server
Single-Tenanted
Hybrid Cloud
Dedicated environment with dedicated server
Single-Tenanted
Private Cloud
Dedicated environment with dedicated server
