Medical Devices
Medical engineering is at the core of advanced diagnostics and medical devices. Whether implants, tools or electronic devices – Constructure provides expertise in many areas of medical technology.
More about our medical device related services
We employ a multidisciplinary approach to solve challenging technical issues in the medical device industry. We support clients with regulatory compliance questions regarding the 2017/745 Medical Device Regulation (MDR) and the Artificial Intelligence Act (AI act).
Constructure conducts design analysis and preclinical testing for cardio-vascular, neurovascular and peripheral endovascular devices (such as stents, stent grafts, heart valves, occluders, ICDs), orthopedic devices (such as hip, knee, spinal implants), dental implants, surgical tools, instruments and machines.
Constructure supports client with questions regarding the use and development of artificial intelligence in combination with medical devices. We also advice on and help implement traditional image recognition and generative AI. Constructure helps with technical documentation according to the MDR and the (upcoming) AI act.
Design Analysis and Testing
- Materials and Particle Characterization
- Design Validation and Verification
- Preclinical standardized and custom testing
Failure Analysis
- Device
- Manufacturing
Regulatory Compliance
- Design Validation and Verification
- Preclinical testing
- Lifecycle Analysis
- Development of regulatory strategy
- Documentation
- Data analysis
Quality Assurance and Documentation
Project Management for planning, research and development
Software and Artificial Intelligence
- Technical implementation of image and pattern recognition
- Generative AI
- Technical documentation (MDR and AI act)
