The U.S. Food and Drug Administration (FDA) www.fda.gov issues guidance documents that represent FDA’s current thinking on a topic. An alternative approach can be used if the approach satisfies the requirements of the applicable statutes and regulations. Relevant guidance documents are reviewed when developing MDT test protocols. A sample of FDA guidance documents we have previously used is shown below.
Working with MDT was a unique experience. The practical expertise they provided coupled with exceptional customer support was a key of success in our academic project. MDT combined their technical knowledge that highly complemented our academic approach with their industry-applications assistance in order to transform theory into reality. MDT cared about our goals.
We have worked with the MDT team for at least 8 years. They have a very professional team which can support all customer needs in testing medical devices. There is a critical mass of knowledge and experience with MDT that enables us to feel comfortable with their testing procedures and results.
Very happy to work with MDT, excellent group of people easy to work. Test was a non-standard test so took thought and a lot of modification to reach a desirable outcome. MDT were an excellent partner in this regard. I appreciated their flexibility greatly.
MDT inventories a broad range of test instrumentation. Their specialized equipment and extensive knowledge of durability testing has enabled them to play an instrumental role in helping us achieve our device submissions in a timely manner. We consider MDT a strategic partner in our development plans.
I'm very pleased with the performance of MDT services, especially the willingness to help, turn around time, and problem solving. I'm glad that we have ready access to you. The services you provide are excellent and important.
MDT has been performing durability testing for us for many years. They have several test machines available to meet our high load requirements. We truly appreciate their flexibility in accommodating our custom test fixtures and unique test parameters. Their responsiveness to our needs and questions is outstanding.
Over the past 6 years, our company has run numerous tests with MDT services, including methods development for a new medical implant. We found that the staff works closely with sponsors to ensure experiments meet the desired purpose; each instance yielded quality service, professional collaboration, and meaningful results.
You have a great team and have been an excellent external resource for us. It takes significant effort and many resources to launch a product like [ours]. Our anticipated success is in no small part due to MDT. You should be proud of your contribution and we thank you.
I was very impressed with the quality of testing services provided by MDT. All staff were quick to respond to any queries or requests and the testing performed was of a high standard.
The work product provided by MDT has driven key aspects of our regulatory submission with regard to our devices structural reliability. Each submission has been successfully audited by several agencies with positive feedback. The outcome of each study has proven to be the standard bearer in our efforts to provide comprehensive and relevant data on our devices performance.