Effective project management throughout the entire product lifecycle: keeping projects in time, on budget, and in compliance with ISO 13485 and 21 CFR 820
Combination Products
Medical Devices
In vitro Diagnostics
Medical Devices
In vitro Diagnostics
Development
Commercialization
In Use
Development
Concept
- Structured user centered concept development
- Innovative requirements management - reduced burden of documentation and improved traceability
- Patient preference studies
Design
- Partner network for industrial design, mechanical design, hardware and software design
- Supplier evaluation and audits
Design Control
- Establishment of EU and US compliant development processes and documentation
Risk Management
- Implementation of risk management processes according to ISO 14971
- Moderation of risk management meetings
Human Factors
- Usability engineering and local support for US or EU handling studies
Clinical Development
- Creation of clinical evaluation according to MEDDEV. 2.7.1 by qualified individuals
- Identification and analysis of relevant clinical data
- Clinical Investigations