Industry Articles
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Learn from Isabella Schmitt, our Director of Regulatory Affairs, who is partnering with Greenlight Guru to discuss, "Company Essentials: The Benefits of a Well-Developed Regulatory Plan.

Watch Isabella's webinar Demystifying The Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes! Thank you to the Greenlight Guru team for sponsoring!

Discover what the top 3 benefits are for breakthrough device and STeP designation applications with the FDA for your innovation or medical device.

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?

Clear Up The Confusion Of Medical Device Biocompatibility Testing Requirements By Discovering The 4 Step Process Of ISO 10993-12.

Learn What Breakthrough Device Designation Is & Why the Automatic BDD Reimbursement Been Paused by the Centers for Medicare & Medicaid Services (CMS).‍

So, you have an idea for a medical device, and you obviously want to take it to the market so that it can have a positive impact on tons of people’s lives and maybe make you a little money as well.

Jon and Isabella discuss some important processes and methods medical device companies should consider for soliciting, receiving, and handling feedback.

When surveying the myriad of pre-clinical testing required to bring your medical device to market, we understand it can be daunting.

Catch Proxima's Regulatory Affairs Manager, Andrew Frink, on Greenlight Guru's podcast on "Why SaMD Companies Should be Leveraging Pre-Submissions to FDA" this week.

Q2 results are in...Here are the top 5 life science accelerators to know now.

Watch our 2020 MTI LIVE Webinar on Clinical Trials & Studies - Pre-Approval to Post-Market. Thank you to the MedTech Innovator team!

Catch Proxima's regulatory affairs consultant, Isabella Schmitt, on Greenlight Guru's podcast on "How to Integrate Usability into your Medical Device" this week.

Catch Proxima's Co-founder & CEO, Kevin Coker, on Greenlight Guru's podcast on "What You Need to Know About Clinical Evaluation & Validation for Software as a Medical Device (SaMD)" this week.

Catch Proxima's regulatory affairs consultant, Isabella Schmitt, on Greenlight Guru's podcast on "How to Integrate Usability into your Medical Device" this week.

Read "Why Understanding Regulatory Affairs is Important to key Company Decision Makers" By Isabella Schmitt, RAC in the latest Regulatory (RF) Article Series.

Catch Proxima's regulatory affairs consultant, Isabella Schmitt, on Greenlight Guru's podcast on "How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory" this week.

Catch Proxima's regulatory affairs consultant, Isabella Schmitt, on Greenlight Guru's podcast on "5 Tips for Hiring Medical Device Advisors" this week.

The FDA introduced a new, voluntary program “Ethylene Oxide Sterilization Master File Pilot Program” that accelerates the documentation processes for sterilization providers and device manufacturers.

Intelligent Implants has been a rising star in the medical device community, winning the Johnson and Johnson CDI Start-Up competition, receiving $250,000 from the TMC Venture Fund, being honored as the Most Promising Life Science Company...

Catch Proxima's regulatory affairs consultant, Isabella Schmitt, on Greenlight Guru's podcast on "Preparing for EU MDR" this week.

The FDA’s new draft guidance on clinical decision support software (CDS) is a major revision of a prior draft guidance issued on December 8, 2017. It explains the FDA’s method of interpreting section 520(o) of the Federal Food, Drug, and Cosmetic Act

In December 2018, FDA announced plans for a new program--the Safer Technologies Program, also known as STeP, and on September 18, 2019, draft guidance for the STeP program was released.

At Proxima Clinical Research, our clinical project managers are here to help you foresee the potential risks in your study as well as help you fix or avoid them altogether.