By clicking “Accept”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our
Privacy Policy
for more information.
Accept
Deny
Preferences
Privacy
Privacy Preferences
Essential cookies
Required
Marketing cookies
Essential
Personalization cookies
Essential
Analytics cookies
Essential
Allow all cookies
Reject all cookies
Save preferences
Follow Us:
Subscribe
Thank you!
Oops!
Submit
About Proxima
Meet our Team
Why Proxima
Careers
We
Innovators
Our Expertise
Solutions
Regulatory
Clinical
Biotech
MedTech
Therapeutic Areas
Oncology
Pediatric
Cardiovascular
Orthopedics & Spine
Neuromodulation
General Surgery
In Vitro Diagnostics
Resources
Company updates
Newsletter
Company News
Blog
Events
Knowledge base
Industry Articles
FAQs
Glossary
Tools & Templates
Video Hub
Breakthrough Device Designation
Accelerator
Submit RFP
Submit RFP
Tools
& Templates
Free resources & downloads
See Downloads
Early Phase Oncology Fact Sheet
Cancer is constantly evolving and so are we. Download this early-phase oncology fact sheet to learn how we help MedTech and biotech companies that are providing next-generation treatments to cancer patients.
Download Resource >>
Traditional 510(k) Timeline Infographic
You're submitting a Traditional 510(k) application and you're wondering how long the approval process will take. Download our Traditional 510(k) FDA Timeline Infographic to learn more.
Download Resource >>
Breakthrough Device Designation FDA Timeline Infographic
Want to learn how long a breakthrough device designation application submission process takes with the FDA? Download this free infographic breaking down the timeline of a breakthrough device designation application for an emerging product.
Download Resource >>
Medical Device Benefit Risk Assessments
Benefit-risk assessments are important tools that help regulators determine whether or not the benefits of your device outweigh the risks.
Download Resource >>
Intro to SaMD
Does your software qualify as a medical device? This resource will help answer this question and also provides tips on how to perform a proper clinical evaluation of your software device.
Download Resource >>
Intro to IVD
In Vitro Diagnostic (IVD) devices often include an entire additional set of regulations on top of general medical device regulations.
Download Resource >>
Intro to ISO 13485
Quality Management Systems (QMS) are important for the efficient management of a product.
Download Resource >>
Intro to HDE
Humanitarian Device Exemptions (HDEs) are for devices that are intended for diseases that affect small populations of people.
Download Resource >>
Intro to De Novo
The De Novo review pathway provides an alternative pathway for novel devices to attain FDA approval.
Download Resource >>
Medical Device Design Controls
Adequate design controls allow you to effectively manage the development of your device, ensure your product meets expectations, and prevent potential issues or recalls in the future.
Download Resource >>
Guide to Effective Medical Device Pre-Sub Meetings
Pre-Submissions(Pre-Subs) are a part of the FDA Q-Sub program, used to help gain FDA feedback before a regulatory submission.
Download Resource >>
Guide to Medical Device Labeling
Labeling is important in the distribution and handling of medical devices. Use this resource to gain an overview of 21 CFR 801, which provides FDA’s regulations and expectations for labeling medical devices.
Download Resource >>
Breakthrough Device Designation
Breakthrough Device Designation (BDD) is a unique regulatory pathway that allows for novel technologies to receive a prioritized and expedited review by the FDA.
Download Resource >>
Medical Devices 101
What is a medical device? What are the different classifications for a medical device? This resource provides a first look at the different types of medical devices.
Download Resource >>
Medical Device Risk Assessment
What is good risk management, and how can your company benefit from it?
Download Resource >>
Medical Device Regulatory Assessments
How should a regulatory assessment be performed? Using this resource, you will learn how to use FDA databases effectively and efficiently.
Download Resource >>
Intro to 510(k)
Does your medical device qualify for a Traditional, Special, or Abbreviated 510(k)?This resource provides an in-depth look into each type of 510(k), the requirements for an FDA submission, and tips on how to improve your submission quality.
Download Resource >>
Medical Device GMP
Good Manufacturing Practices (GMPs) are regulations that ensure the safety, purity, and effectiveness of drugs, medical devices, food, and more.
Download Resource >>
Intro to PMA
The Premarket Approval (PMA) pathway is the most stringent of the FDA regulatory pathways.
Download Resource >>