Providing medical device and engineering advice to the healthcare industry.
Our services in healthcare engineering
- Regulatory Affairs
- Clinical affairs
- R&D and Engineering
Healthcare as key challenge
The ageing of the population, the cost of treatment, the need to improve the patient experience and therapeutic innovation are all challenges facing the healthcare sector. But tech can provide solutions.
Telemedicine and connected medical devices linked to monitoring applications facilitate Support patients, improve their quality of life, reduce costs and promote prevention. In the field of clinical trials, artificial intelligence facilitates a precise analysis of the data collected, enriches clinical documentation and thus accelerates the development of new therapies. The implementation of these digital technologies and the sharing of data require increased vigilance in terms of cyber security.
Thus, in addition to doctors, paramedics and scientific researchers, it is now essential that the healthcare ecosystem includes experts capable of proposing reliable technological solutions adapted to their profession. AMEG GROUP is committed to working alongside them in accordance with the most advanced regulatory and normative requirements.
Design of new medical devices
- Proposal of different concepts and technical solutions
- Study and design of the functions of the device desired by the client
- Establish and validate product coastlines
- Monitoring of prototypes, tests
Development of new medical devices (project management)
- Follow-up of studies
- Validation of coastlines
- QCD monitoring of the project
- Drafting of protocols
- Direct link with the customer, suppliers and factories
- Statistical analysis and analysis report
- Monitoring and reporting of tests
Participation in the drafting of specifications (URS)
- Technical expertise in various syringe development projects
- Responsible for technical documentation (product requirements document, bill of materials, product design specifications, essential design outputs, design verification test reports, design verification summary report, design history file index...)
- Monitoring of laboratory activities (mainly mechanical tests on syringes).