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 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.
You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter.
You need to know the timelines and costs related to developing a new medical device.
You are preparing your own 510(k) and are looking for a real example to guide you.
Free Notion-powered eQMS, ALM, RIM, and FDA approved templates.
FINANCE/HR ADMIN
Joined: July 29, 2019
Needlework; cooking; reading historical novels
