Medical Device Testing
GVRP provides comprehensive medical device testing services that ensure the safety, efficacy, and regulatory compliance of your medical devices. Our state-of-the-art facilities, expert team, and adherence to global standards position us as a trusted partner in bringing innovative medical technologies to market (ISO 10993, ISO 25539-2: 2012 and 21 CFR 58 / GLP)
Our Medical Device Testing Services
Biocompatibility Testing
We conduct thorough biocompatibility assessments in compliance with ISO 10993 standards to evaluate the interaction between your device and biological systems.
Cytotoxicity Testing
- Assessment of cell viability in response to device materials.
Sensitization Testing
- Evaluation of the potential for an allergic response.
Irritation Testing
- Analysis of local effects after exposure to device components.
Implantation Studies
- Long-term evaluation of the device’s performance and biocompatibility in vivo.
Cardiovascular segment devices
| Device Type | Description |
|---|---|
| Cardiac Rhythm/Flow Management Devices | Defibrillators, pacemakers |
| Interventional Cardiac Devices | Stents, catheters, angioplasty balloons |
| Cardiac Monitoring/Diagnostic Devices | Telemetry systems, electrocardiograms (ECGs) |
| Peripheral Vascular Devices | Stents, grafts, balloon catheters |
| Electrophysiological Devices | RF ablation catheters, laser catheters, 3D mapping systems |
| Prosthetic Devices and Ventricular Function Devices | Prosthetic heart valves, ventricular assist devices (VADs) |
Genitourinary segment devices
| Device Type | Description |
|---|---|
| Urinary Incontinence Devices | Macroplastique, urethral sling implants, nephrostomy tubes, urinary stents |
Neurological segment devices
| Device Type | Description |
|---|---|
| Neuroplasty Implants | Cochlear implants |
| Renal Denervation Ablation Devices | RDN catheters |
Dental devices
| Device Type | Description |
|---|---|
| Dental Implants | Endosteal, endosseous, single-stage, subperiosteal |
Integumentary implants devices / therapeutics
| Device Type | Description |
|---|---|
| Hemostats & Sealants | Medical adhesives, hemostatic agents |
| Cellular Implant Therapies | Stem cell therapies, tissue engineering |
Orthopedic segment
| Device Type | Description |
|---|---|
| Tissue Engineered Grafts | Bone grafts, cartilage grafts |
| Knee Replacement Implants | Metal, ceramic implants |
Gastrointestinal segment devices
| Device Type | Description |
|---|---|
| Nasogastric Tubes | Feeding tubes |
Regulatory and Compliance Support
Navigating the complex regulatory landscape is critical to bringing your medical devices to market. We offer expert guidance and testing services that align with global regulatory requirements.
FDA Pre-Submission Support
- Assistance with documentation and testing requirements for FDA submission.
GVRP adheres to international standards, including ISO, IEC, and ASTM, ensuring that your testing meets the stringent requirements for global market approval.
We work closely with your team at every stage of the development process, offering personalized support and consultation to address your specific testing needs and challenges.
