Medical Device Testing
Unparalleled expertise in research & development and preclinical testing of medical devices and combination drug/device products
- Every device is unique -- rapid commercialization of a safe and effective product requires expert guidance
- SynecorLABS offers full-service medical device testing & evaluation from prototype to commercial product:
- Proof of concept
- Feasibility
- Research & development
- Functionality
- Efficacy
- Safety
- Biocompatibility
- GLP studies for regulatory submission to FDA in support of 510(k) or IDE
- Non-GLP studies adhere to stringent Research Quality Standards developed to ensure the quality of every study performed
world-clasS training facility
- Interventional and surgical training for physicians, technicians, sales, and corporate personnel
- Standardized training to ensure adherence to your clinical trial protocol
- Inanimate tissue program
Facility & Equipment
- Three state-of-the-art operating rooms / interventional suites that exceed clinical caliber
- Industry leader in medical imaging capabilities
- Fluoroscopy/angiography
- Optical coherence tomography
- Echocardiography
- Intravascular ultrasound
- Endoscopy
- Laparoscopy
- Comprehensive surgical & procedural capabilities
- Endoscopy
- Laparoscopy
- General and subspecialty surgery
- On-site housing of test subjects
- Fully-equipped necropsy room
