Comprehensive Medical Device Analysis
Gateway Analytical provides critical testing for medical device development, a vital step mandated by regulatory agencies. Our comprehensive range of tests focuses on meeting the requirements for particulate matter contamination and potential extractable and leachable compounds. It rigorously assesses the potential of medical devices to harm patients or users to ensure integrity and well-being. Our cutting-edge solutions ensure the safety, efficacy, and regulatory compliance of your medical devices. Explore our range of specialized testing services tailored to meet the complex demands of the medical device industry.
Where Innovation Meets Excellence.
How is Gateway Analytical keeping up with the latest technology for medical device analysis?
Gateway Analytical continues to stay up to date on the latest methodology for medical device analysis to ensure customers are compliant with current ISO specifications and requirements. Gateway Analytical is alerted with any potential change to the methods, and all trained analysts are required to perform analyses in accordance to the update.
How does Gateway Analytical guarantee safety among their samples?
Gateway Analytical performs all analyses for medical devices in an ISO Class 5 laminar flow hood with all essential PPE to ensure optimal cleanliness and safety during the sample handling process.
Which guidelines does Gateway Analytical use to determine study design?
When determining study design, Gateway Analytical follows relevant ISO procedures dependent on the submitted device. Gateway Analytical’s team of expert scientists assists customers in developing configurable test methods to meet their needs.
Does Gateway Analytical provide time points when performance should be evaluated in medical devices?
Although Gateway Analytical does not provide time points when performance should be evaluated in medical devices, the team of experts are always at the customer’s disposal for any guidance relevant to their device.
Will the device analysis provide information on regulations needs and risk factors?
All analyses at Gateway Analytical yields beneficial information to the customer about their specific device in regards to regulations needs and risk factors. Gateway Analytical has helped customers determine malfunction within a lot of devices and assist customers in characterizing unwanted particulate to support source determination.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Empowering Your Journey Toward Enhanced Patient Care
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.