Paxmed International

one of our company representatives met one of Paxmed's regulatory specialist at a validation seminar this year. our company later followed up with her to discuss their consulting services in pre-market trials. we enlisted their consulting services study strategy, design and protocol development. there are a lot of legality issues that go into marketing our device and the expertise of Paxmed's consultants lead us through every step through the pre-market phase. we received regular follow-up conferences with our designated team in paxmed and our our deadline was met a few days early. this gave their team time to look over the final plan before an additional time before submission. we would recommend others in the industry to reach out to Paxmed for regulatory needs.

Strengths: works with companies of all sizes for medical device, high integrity approach to studies, regulatory product review, regulatory compliance, consulting services range from regulatory submissions, clinical trails, and quality systems development.

Needs to improve: none

They have truly deep knowledge of regulatory affairs and are great people with whom to work.

Strengths: Floyd knows an incredible amount about the regulatory world for medical devices. He is heavily involved in ASTM and ISO, who set these standards.

Needs to improve: The pricing structure can be high, even for medical devices. However, this more than made up by the knowledge and speed to market that Paxmed brings.