Service provider for medical device approvals, QM systems and regulatory project engineering
ascendi Medizintechnik
NurembergNew on Amplifa
About ascendi Medizintechnik
ascendi Medizintechnik is a consulting and engineering service provider for medical device approvals based in Nuremberg. The company supports manufacturers throughout the entire product life cycle: from approval strategy through qualification and classification to post-market surveillance. Approvals are managed for all risk classes (I–III) in Europe, the USA, Canada, Australia and China. Further services include implementation, updating and harmonization of QM systems, GAP analyses, audits, ISMS, preconfigured project plans for QM processes, technical documentation and approvals, as well as FDA preparation including inspection, cybersecurity and mock audits. In addition, ascendi offers requirements management, AI processes and training (QM, product approvals, medical device consultant, PRRC). Customers include companies such as XENIOS AG, Maquet Cardiopulmonary GmbH and Olympus.
- Site
- Nuremberg
- Processes
- Medical device approval (all risk classes I–III, Europe, USA, Canada, Australia, China), QM systems: implementation, updating, harmonization, model processes, GAP analyses, ISMS, Project management/project engineering (QM processes, technical documentation, approvals, audits), FDA: US market entry, FDA inspection, cybersecurity, mock audits, Post-market surveillance, Requirements management, cybersecurity development, AI processes and applications, traceability, Training (QM system, product approvals, medical device consultant, PRRC), Medical device approvals (Europe, USA, Canada, Australia, China; risk classes I–III)
- Materials
- Medical Device Approvals, QM Systems, FDA Processes, Post-Market Surveillance, Training
- Founded
- 1999
- Industries
- Medical Technology, Medical Devices
- 01
Requirements management
- 02
Approval strategy and classification
- 03
Implement/harmonize QM systems
- 04
Project engineering and technical documentation
- 05
Approval or FDA process
- 06
Post-market surveillance
Service Portfolio
Medical Device Approvals
Approvals for risk classes I–III in Europe, the USA, Canada, Australia and China.
QM Systems
Implementation, updating, harmonization, model processes, GAP analyses, ISMS and audits.
FDA Processes
Market entry in the USA including FDA inspection, cybersecurity and mock audits.
Post-Market Surveillance
Regulatory support after market entry.
Training
Training on QM systems, product approvals, medical device consulting and PRRC.
Location
Nuremberg
DEOffice/Headquarters
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Medical device approval (all risk classes I–III, Europe, USA, Canada, Australia, China)Engineering | – | – | – | – | – |
| QM systems: implementation, updating, harmonization, model processes, GAP analyses, ISMSEngineering | – | – | – | – | – |
| Project management/project engineering (QM processes, technical documentation, approvals, audits)Engineering | – | – | – | – | – |
| FDA: US market entry, FDA inspection, cybersecurity, mock auditsEngineering | – | – | – | – | – |
| Post-market surveillanceEngineering | – | – | – | – | – |
| Requirements management, cybersecurity development, AI processes and applications, traceabilityEngineering | – | – | – | – | – |
| Training (QM system, product approvals, medical device consultant, PRRC)Engineering | – | – | – | – | – |
Additional services
Reference customers
History
- 1999
Foundation of ascendi Medizintechnik by Dieter Velte after 11 years of industry experience as product manager and QM officer.