DENTAL & MEDICAL TECHNOLOGY
PROJECT MANAGEMENT
Project Management according to IPMA Standard
Context & boundary analysis
Cost & resource planning
Project coordination & controlling
DOCUMENTATION
Creation of the product file
according to MDR and national regulations
Creation of the QM system
according to ISO 13485
Risk management documentation
according to ISO 14971 and usability
according to IEC 62366-1
Creation of technical documentation and consulting for proof of electrical safety
according to IEC 60601
Software life cycle documentation
according to IEC 62304
Preparation of further normative required documents e.g.
functional specifications, instructions for use, procedural instructions
TECHNICAL CONSULTING
Support in the selection of accessories for your dental and medical products including communication with suppliers
Construction of cabling and pneumatic diagrams
Support during certification including consultation with test centers
Support after certification
MEDICAL PRODUCT SERVICE
GENERAL INFORMATIONEN
According to the MDR dental and medical devices must be inspected recurrently, between 12 and 36 months.
The frequency of the inspection depends on the type of device and the manufacturer’s specifications.
MAINTENANCE & REPAIR
The device is maintained and inspected on site, taking into account your daily operations.
We will support you by suggesting solutions to remedy any deficiencies found.
All repairs are carried out promptly and in compliance with all normative requirements.
INSPECTION ACCORDING TO
IEC 62353
Medical electrical device
MDR
Medical Device Regulation
CUSTOMERS & REFERENCES
Our customers are manufacturers of dental and medical devices, physiotherapy centers and dental clinics
in Austria and Germany.
Our goal is not only comprehensive advice and support, but also optimal pricing.
CONTACT
DAVID dental medical solutions e.U.
- Ing. Philipp DAVID
Weilhartstraße 49b
A-5121 Ostermiething
You can reach us by phone
Mo – Thu
08:00 – 17:00
Fr
08:00 – 13:00