Developing Solutions That Meet Your Needs
When it comes to product development, you need a partner who can guide and support you through every touch point of the process — from model development to regulatory submission and beyond. Yet, more than a generalist, the right partner will also need to be able to anticipate and meet your unique product development needs.
Our team offers highly specialized expertise in identifying the technical complexities associated with disposable and reusable therapeutic medical devices. Then, we work with you to craft the innovative strategies and solutions that overcome these challenges, to make your vision for medical device innovation a reality.
Together, we can help your team create designs, generate documentation, perform verification and validation testing, and more providing seamless support and keeping you on time and on budget, every time.
- Concept generation to support design or to help strengthen your intellectual property portfolio
- Model generation
- Concept evaluation through prototyping and analysis
- Design for manufacturing
- Design verification testing
- Biocompatibility testing
- Failure modes and effects analysis (FMEA)
- Supply chain FMEA
- Risk management
- Packaging development
- Development of product for clinical trials
- Validation and verification protocol development and execution
- Regulatory submissions, both US and OUS
- Design reviews
- Documentation generation ranging from drawings to complete design/device history files
- Final manufacturing strategy