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).
We perform 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.
Design Analysis and Testing
- Materials and Particle Characterization
- Design Validation and Verification
- Preclinical testing
- Testing in accordance with ISO or ASTM standards
- Custom testing
Failure Analysis
- Device
- Manufacturing
Regulatory Compliance
- Design Validation and Verification
- Preclinical testing
- Lifecycle Analysis
- Development of regulatory strategy
- Documentation
- Data analysis
