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Effective Post-market Surveillance in the EU under MDR
The European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/ IVDR) should make for a healthier medical device landscape in the EU once implemented.
March 2021
MedTech Innovator Partner Spotlight: Proxima Clinical Research
Check out our Co-Founder & COO, Jaye Thompson, speak with MedTech Innovator.
June 24, 2020
Best Practices for Preparing and Conducting Pre-Submission Meetings
This Session Will Cover: Creating the best packet possible – common pitfalls; Strategies for conducting quality meeting; Observed differences between divisions
June 2, 2020
Meet the Innovator: Alton Reich, Vital Metrix | Co- Founder & CEO
Vital Metrix won the “Best Biometric Sensor Solution” award from MedTech Breakthrough in 2019, and has participated in several accelerator and incubator programs.
April 3, 2020
Global Medical Device Podcast: How to Integrate Usability into your Medical Device
Catch Proxima's regulatory affairs consultant, Isabella Schmitt, on Greenlight Guru's podcast on "How to Integrate Usability into your Medical Device" this week.
April 1, 2020
Global Medical Device Podcast: What You Need to Know About Clinical Evaluation & Validation for Software as a Medical Device (SaMD)
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.
April 1, 2020
"The Strategic Role of the Regulatory Professional", Regulatory Focus
Read "Why Understanding Regulatory Affairs is Important to key Company Decision Makers" By Isabella Schmitt, RAC in the latest Regulatory (RF) Article Series.
March 12, 2020
The Greenlight Guru True Quality Roadshow
What are market-leading companies doing to accelerate product development, ensure compliance, and promote quality? How can key stakeholders think differently about critical challenges that arise?
February 25, 2020
Global Medical Device Podcast: How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory
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.
February 25, 2020
Newsletter: Oxytocin anyone? | February 14, 2020
The "V" edition - Viral outbreaks, Venostent, "Vaping" and Valentines Day
February 14, 2020
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