your partner in medical and
industrial business
what we do for you
our services
- consulting
- quality management
- regulatory affairs
- interims management
- project management
- medical technology
- research & development
- verification & validation
- special services
for more details explore our website!
consulting
- appropiration of funds
and startups
- risk management
- process optimizing
quality managemant
- quality system development
and maintenace
- Auditing
(Internal & Supplier Audits)
- ISO 9001, ISO 13485
regulatory affairs
- Regulatory support
(idea through design and
registration to commercialisation)
- Medical Directives
93/42/EEC, 2007/47/EC
- Combined Products
- CEmdd, FDA
interims management
interims management as
- project manager
verification + validation
- quality manager
- safety engineer
- product manager
project management
- Project Process
Design and Execution
- Project Controlling
- Project Plans
- Team Leadership
(employees + consultants)
medical technology
- Product Risk Management
- Usability Engineering
- Normative Standard TRFs
- Biocompability
- Sterile, active, passive, combined
Products
- Software Development Lifecycle
- Post Market Surveillance, CAPA
- Technical Documentation
- Labelling, IFU-, Service-Manuals
- REACH, ROHS, ISTA2, UL
research & development
- pc based measurement systems
- test place design
- transducer development
- analog electronics
verification & validation
- verification / validation
master plans
- verification / validation plans
- development of test designs and
pc based measurement places
- test reports
- Clinical Evaluations
- Clinical Studies
summary reports
- v-modell
special services
- instructions for use /
service manuals acc. to
normative requirements
- marketing material
- professional photos / studio
|
|
|
|
|
|
|
|
|