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Learn how to identify, minimize, and manage biases in AI for medical applications with this in-depth guide.

Learn from Isabella Schmitt, our Director of Regulatory Affairs, who is partnering with Galen Data to discuss, "Reducing AI Risk to Secure Regulatory Approval."

In the Wellness Device Playbook blog series, we’ll break down the qualifications, claims, and other related elements for marketing a device as a Wellness product.

Let’s review the main elements for why, when and how to implement a quality management system. This is a key part of your MedTech or biotech product development.

Learn a patient-centric approach to overcoming patient recruitment challenges in oncology clinical trials from our experts at Proxima Clinical Research, here!

A successful clinical trial depends on the recruitment and retention of patients, which can be challenging. Learn the strategies to implement in your study!

We work with innovative biotech & medical device companies across all phases of development; including writing your clinical trial protocol. Get to market quickly with our full suite of services.

Do you know if your MedTech device should receive FDA Clearance or FDA Approval? How does this process work? Learn the process from our team of regulatory experts, here!

Contract Research Organizations (CROs) assist businesses in making the best use of their CPRIT funds by providing oncology trial designs and budgeting resources. Continue reading to find out how oncology CROs can help with grant support.

As a regulatory consulting and clinical trial execution firm that ensures MedTech companies and their products adhere to all regulatory standards and developmental life cycles, Proxima is ready to take the pain out of your PMA (Pre-Market Approval).

Learn from Isabella Schmitt, our Director of Regulatory Affairs, who is partnering with Greenlight Guru to discuss, "Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)"

M1 combines funding, entrepreneurial advice, expert services, and a one-of-a-kind curriculum to accelerate the next generation of MedTech companies

We’re going to sink our teeth into the world of AI and MedTech dentistry. We’ll cover the limitations of modern dentistry, the improvements AI offers, and the challenges of incorporating AI into this field.

M1 combines funding, entrepreneurial advice, expert services, and a one-of-a-kind curriculum to accelerate the next generation of MedTech companies

Get the heart of MedTech by learning the top 3 things you need to know for submitting your cardiovascular medical device for review with the FDA.

Learn from Isabella Schmitt, our Director of Regulatory Affairs, who is partnering with Greenlight Guru to discuss, "Is Regulation Necessary for Quality?"

What is the De Novo review pathway with the FDA? How does this process work for medical device companies? Learn if your product is right for De Novo, here.

Want to learn the ins and outs of the FDA’s ASCA Pilot Program? Learn from an experienced MedTech CRO team.

What makes the Special 510(K) Program so special? Learn what makes this program unique for marketed medical devices & get quick responses from the FDA.

In Project MedTech's podcast hosted by Duane Marcini, Isabella discusses M1 Accelerator, the importance of regulatory strategy, why startups shouldn’t be afraid of a PMA & much more!

Inventing Tomorrow Podcast: The Conception of Ideas with hosts Kevin Coker and Isabella Schmitt. Sponsored by Proxima Clinical Research.

The 510(k) program is an important early-stage process with the FDA. Learn the details of your device's 510(k) journey & what to consider in your application.

Read Kevin Coker's article in about the top considerations when selecting a CRO in Med-Tech Innovation News.

Check out Isabella's latest article with Healthcare Business Today on how The Time is Now for Pediatric Device Development to be Centerstage

Do You Want To Learn The 10 Major Principles For Artificial Intelligence And Machine Learning Changes? The FDA, Health Canada & More Agencies Shared What Needs to Happen For Better AI Development.