Medical Device Testing
The Federal Food and Drug Administration (FDA) is the agency responsible for protecting the public health by assuring the safety, effectiveness, quality, and scrutiny of medical devices.
The biological evaluation of medical devices is an important step in development. With over 40 years experience, Product Safety Labs is able to offer a comprehensive list of supporting tests. Whether your need is biocompatibility testing according to ISO 10993 or microbiological testing within development, production and finished product testing, we will support you with individual testing strategies and study designs to fulfill your needs. In addition, we offer chemical characterization of materials for extractables and leachables according to ISO 10993-18.
Our Services for Medical Device Testing Include:
- Biological Safety Testing including Biocompatibility Tests
- Microbiological Safety Testing
- Physicochemical Evaluation
- Extractable and Leachable Testing
Medical Device Development at a Glance
Let one of the experts at Product Safety Labs help you develop a study to meet your objectives.