Why INNUXO
- Rapid and agile deliver
- Trustworthy and independent partner
- Passionate and engaging team
- Longstanding expertise
- Recruiting and test studio capabilities
- Seamlessly integrated into your processes
- Results ready for notified body
Medical Device Development
Besides Usability Studies, we can provide you with an overview of the relevant directives, laws, regulations and guidelines. Our team of experienced human factor specialists can assist you to minimize risks and can design and validate medical devices in co-creation with you - fast and lean.
Quality is particularly important to us. This is why we work according to the following standards:
- IEC 62366-1
- EN ISO 14971
- IEC 62304
- ISO 9241
- ISO 13485
- FDA Guidance Documents
Our Other Services
The Medical Device Life Cycle
In collaboration with our partner, FSQ Experts, we offer comprehensive services across the entire medical device lifecycle, from the initial concept to post-market surveillance. Each stage is critical in ensuring the safety, efficacy, and regulatory compliance of the device or software.
We specialize in the early phases of the life cycle, focusing on:
- Ideation Workshops
- User Research
- Usability Engineering
- Industrial & UX/UI Design
- Usability Evaluations
We work closely with our partners who provide expertise in:
- Project Management
- Risk Management
- System Engineering
- Quality Management
- Regulatory Affairs to ensure a seamless and successful journey through the entire process.
By working collaboratively and leveraging our expertise in each stage, we help our clients navigate the complexities of the medical device life cycle and bring innovative solutions to market.