Medical Device
We provide complete research, product development, regulatory and manufacturing services medical device and healthcare companies. We help our clients develop innovative new solutions that improve outcomes and enhance lives—and get them to market with commercial success.
Our team has expertise in all areas of Medical Device Development from proof of concept to pilot manufacturing.
We have:
- Insights in various surgical specialties including Gynecology, Urology, Cardiology, Orthopedics, Cosmetic Surgery and General Surgery.
- Proven experience with US FDA & CE requirements.
- Experience of working in North American and European markets with leading medical device companies and individual innovators.
- Assures complete confidentiality.
- Positioning the Client in a superior cost position by offering services that saves significant cost of the medical device development.
Product development services:
- Domain Knowledge
- Concept Generation & Selection
- Concept Refinement
- Concept Detailing
- Prototyping
- Pilot Manufacturing
Post product development services:
- Packaging and Sterilization
- Clinical Verification
- Clinical Validation
- Regulatory submission