Medical Devices and Diagnostics: Regulatory Submission and Launch

FDA Devices Submission is the final stage to get the medical device product to market.  A successful submission to the FDA is critical for a speedy approval in addition to establishing efficient and effective manufacturing process. A substantial amount of testing is required to evaluate safety of the device and demonstrate control of the manufacturing process. EAG Laboratories has years of experience in extractables/leachables, ISO 10993 Part 18 testing, and contamination control.

Final testing programs are performed on multiple manufactured batches of the device to evaluate biocompatibility and validate manufacturing for submission to the regulatory bodies.  An appropriate testing program is required factoring in application and end use to provide a realistic evaluation of the device. EAG has developed approaches to extractables/leachables and ISO 10993 Part 18 for evaluating the chemical characteristics of biocompatibility.

EAG has laboratories with GMP compliance, ISO 17025 and ISO 9001 certifications depending on the needs of our customers. This level of quality management combined with scientific expertise and capabilities offers a compelling solution to ensuring a successful regulatory devices submission.

We recognize the importance of having a broad range of capabilities combined and have technical experts available for discussion.   Please call us at 800-366-3867 to speak with one of our scientists about your study.

 

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