ascendi Medizintechnik

ascendi Medizintechnik ensures the safe and efficient approval of medical devices—internationally and across all risk classes. We establish the necessary prerequisites (regulatory requirements, quality management systems), manage and support the entire development process (project planning), and ensure the completeness of the documentation (product approval, certification/recertification by regulatory authorities).

Medical Device Approval

Entire approval process, including:

• Qualification
• Classification
• Approval Strategy
• Postmarket Surveillance
• Quality Management Systems
• Sample Processes
• GAP Analyses
• ISMS
• Audits
• Project Management

Preconfigured project plans for:

• QM processes
• Technical Documentation
• Certifications
• Audits
• FDA

Entry into the U.S. market, including:

• FDA Inspection
• Cybersecurity
• MOCK Audits

• Requirements management for all applicable regulations, product, and market requirements
• Cybersecurity Development
• AI processes and applications
• Traceability throughout the entire product life cycle