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Kevin Coker: Are Tall Tales Detracting Investors?
Read Kevin Coker's article about why tall tales are detracting investors for start-ups in Healthcare Business Today.
The 510(k) Program – All About This Submission Type
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.
Kevin Coker: Three Tips For New Entrepreneurs To Build Investor Excitement Without Lying
Read Kevin Coker's article about 3 tips for new entrepreneurs to build investor excitement without lying in Forbes Business Council.
Kevin Coker: Top Five Considerations When Selecting a Contract Research Organisation
Read Kevin Coker's article in about the top considerations when selecting a CRO in Med-Tech Innovation News.
The Proxima Playbook: Who Wants to be a Wellness Device?
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.
Major Guidance Changes to Artificial Intelligence and Machine Learning
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.
Top 3 Benefits of Breakthrough Device Designation or STeP Designation
Discover what the top 3 benefits are for breakthrough device and STeP designation applications with the FDA for your innovation or medical device.
The growing femtech industry needs more attention — and funds, says this Houston expert
Read our Director of Regulatory Affairs, Isabella Schmitt, talk about femtech & investments in the recent Innovation Map Article.
Tackling ISO 10993-12 Biocompatibility
Clear Up The Confusion Of Medical Device Biocompatibility Testing Requirements By Discovering The 4 Step Process Of ISO 10993-12.
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