invenio develops active and inactive medical devices of all risk classes as well as implants according to your individual requirements. Our expertise ranges from mechanical to mechatronic products to stand alone software. We follow the processes of our quality management system according to DIN EN ISO 13485 (certification for development and verification services in the field of electromechanical medical products) and DIN EN ISO 9001 as well as the idea of 'Good Manufacturing Practices (GMP, GxP)'.
Through our interdisciplinary teams of engineers, physicists, chemists and biologists, we have more than ten years of experience in the development of medical technology. The Design Control Process serves as a guideline from 'Design Planning' to 'Design Validation'.
We offer the following services:
-
Mechanical and Electronic Systems
-
Embedded and Application Software
-
Prototyping
-
Method Development and Validation
-
Development of test equipment including Qualification
-
Evaluation and Verification Tests
-
Reporting
-
Innovation Workshops
-
Process Modelling
-
Technical Documentation for your registration documents
-
FMEA accompaniment
-
Usability Engineering
-
Clinical Evaluations
-
Connectivity and Cybersecurity
-
DIN EN ISO 13485:2016
-
DIN EN ISO 9001:2015
-
DIN EN ISO 14001:2015
-
BS OHSAS 18001:2007
invenio provides all certifications for download.
We develop for customers from all over the world in the areas of pharmaceutical industry, general medical technology and dental technology. We have executed the following exemplary projects in the past:
-
Mechatronic compact infusion system for dosing pharmaceuticals (micropump)
-
Derivative development for pen injectors
-
Benchmark analysis of auto-injector systems
-
Complete development of a steam small sterilizer for the US market
-
Complete development of a mobile surgical suction pump for dental use
-
Percutaneous Endoscopic Gastrotomy (PEG) Systems
-
Subsystem of a dental treatment unit
-
Re-design of a stomach tube for enteral nutrition
-
Manual assembly equipment for assembling combination products
-
Patent analysis for dialysis machines
-
Needle-based Injection Systems (NIS)
- Verification Tests
Benefit from our full-service portfolio – we look forward to your challenge!
Would You like to contact us?
Gladly we are at your disposal for any questions!
