The Medical Device R&D outsourcing is increasing owing to the following factors:
- Globalisation
- Increasing speed to market
- Developing products for emerging economy
- Cost
- Adaptation of technology
One more point is about designing the products based on specific customer requirements. It could be to solve an existing problem, developing a product for a niche segment and so on. New product designs are emerging quickly based on customer feedback and reviews.
We at Caliber Assurance Services believe that we have a role to play in this complex world of R&D services.
We cater to the following Medical Device Industry Segments:
- Vital Monitoring
- Medical Imaging
- Surgical Technologies
Our Services include the following for Medical Device OEMs:
- Hardware and Embedded Design
- Renesas , PIC, Free scale ARM based Controller Design
- Embedded C, C++
- Graphical LCD Interface Design
- I2C, SPI, RS232, RS 485, CAN Interface
- Mechanical Engineering Services
- System Integration
- Design Qualification and Verification Services
- QMS Consulting per 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, IEC 62366
- Product Compliance testing per IEC 60601-1
- Design Change and concurrent Engineering
- Post Marketing Surveillance
- RCA / CAPA
