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You need a software-development partner for a new or existing medical-device product.
You need to determine the best path to the US market or have other custom regulatory needs.
You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter.
Empower medical device innovation with our solutions for particular business situations.
You have a nearly finished product but no documentation, and need to submit a 510(k) ASAP.
You need guidance, training, templates, and document review support for a 510(k) submission.
We guarantee submitting your AI/ML SaMD FDA application in 3 months and guarantee FDA clearance.
We guarantee submitting your presub and BDD in 2 weeks.
You need Quality Management System implementation and/or support.
MARKETING MANAGER
Joined: March 20, 2024
