Medical Device Testing
Medical device testing is a critical component in maintaining patient and healthcare provider safety, delivering quality healthcare, and regulatory compliance. Partnering with IBEX Preclinical Research gives you access to full-service support that includes meticulous medical device testing and development of protocols for FDA submissions.
Quality Medical Device Testing Services
Medical device testing involves rigorous evaluations, including biocompatibility and mechanical performance. Testing also helps identify design flaws or functionality issues early in the development process, reducing the risk of product recalls and liabilities while ensuring the devices perform as intended under different conditions.
Partnering with a team that has extensive product development experience and FDA regulatory submissions ensure that your product gets the attention it deserves.
IBEX Preclinical Research Inc. has for over 20 years successfully guided many clients across the country through the medical device testing process. From product design and development, testing, and FDA submission support, we are the team to get it right, every time.
Contact us today and let’s discuss your next medical device testing project.
Medical Device Testing Service From IBEX Preclinical Research Inc.
We offer a tailored approach to assess your device’s safety and effectiveness. Our services include in-depth evaluations such as biocompatibility testing, mechanical performance, and long-term implant safety using both GLP (Good Laboratory Practice) and non-GLP methodologies. We specialize in deploying medical devices in various animal models and performing efficacy assessments to simulate real-world clinical applications. Not sure which approach fits your program? Our comparison of GLP vs. non-GLP study design explains when each one makes sense.
Our team of experienced veterinary surgeons and research technicians ensures that each procedure is conducted with precision, providing reliable and reproducible results. By combining technical expertise, high-quality research standards, and a strong commitment to complete confidentiality, we ensure that you receive the support you need to advance your products through preclinical development and into successful clinical trials.
Call us today to schedule a consultation.
Our Service Process
Contact us today, and let us handle your orthopedic preclinical research for your next product.
- Study Design
- Protocol Development
- Preclinical Testing Preparation
- Testing (in-vivo and lot release)
- Data Collection and Monitoring
- Data Analysis and Reporting
- Regulatory Compliance Review
- lient Consultation and Recommendations
Benefits of Partnering With IBEX Preclinical Research Inc.
Experienced and Skilled Team
The IBEX team comprises highly skilled veterinary surgeons, research technicians, and GLP experts with decades of combined experience, including the surgeons who design every device protocol. Working out of the imaging and surgical suite where device studies run, this team handles simple to complex medical device testing, from orthopedic implant and spine device studies to soft tissue and interventional work, providing you with trustworthy data for critical decision-making.
Extensive Experience with FDA Submissions
We are well-versed in the stringent requirements needed for regulatory approval, including FDA’s preclinical research and prototype step, and can help you navigate the complexities of the submission process and facilitate smoother interactions with regulatory agency.
Confidentiality and Data Security
You can trust that your sensitive information remains confidential throughout the study and beyond, safeguarding intellectual property and competitive advantage.
Medical Device Testing FAQs
How long does it take to complete a medical device testing study?
The duration of medical device testing varies depending on the type and complexity of the tests required. Basic biocompatibility tests may take days to weeks while more complex studies, such as long-term implant evaluations or clinical trials, can take several months to over a year.
What are the key considerations for choosing a testing laboratory?
Key considerations include the lab’s accreditation, experience with specific device categories, compliance with GLP standards, turnaround times, confidentiality policies, and expertise in regulatory submissions. Choosing the right testing laboratory ensures accurate and reliable data for successful regulatory approvals.
How do you ensure the confidentiality of proprietary information during testing?
Our testing laboratories implement strict data security protocols, including confidentiality agreements, restricted access to data, and secure storage systems, to protect sensitive client information.
Preclinical Research Services
Testing laboratories implement strict data security protocols, including confidentiality agreements, restricted access to data, and secure storage systems, to protect sensitive client information. Confidentiality is critical to maintaining competitive advantage and protecting intellectual property
