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The Nemedio Blog: Demystifying Compliance
your guide to product development and compliance for medical technology
On Demand Webinar
Crash Course on Medical Device Compliance
Medical device compliance is hard. Learn the basics during this webinar.
February 17, 2022
Recent Posts
Classifying Medical Device Software
July 11, 2022
Why medical grade is bare minimum
July 4, 2022
What are the requirements for a software as a medical device?
June 27, 2022
Previous Posts
Classifying Medical Device Software
July 11, 2022
Why medical grade is bare minimum
July 4, 2022
What are the requirements for a software as a medical device?
June 27, 2022
FAQ
How do you keep your investors at ease while communicating with the FDA?
June 20, 2022
What is an IDE and do I need one?
June 14, 2022
FAQ, Regulatory
EUA is over - what does that mean?
June 10, 2022
FAQ
How do I choose a sterilization technique?
June 7, 2022
Wireless coexistence for medical devices
June 2, 2022
Tips for 3D Printing and Medical Devices
May 30, 2022
FDA, Regulatory
How NOT to hold a pre-sub
May 25, 2022
Compliance, Quality
Quality agreement versus business agreements
May 23, 2022
FAQ
Clinical Study before QMS?
May 19, 2022
FAQ
I’m building a medical device. Do I *need* to do a clinical study?
May 12, 2022
FDA, Regulatory, FAQ
Most Common Reasons for Warning Letters
May 9, 2022
Software
Software as a Medical Device versus outside software
May 6, 2022
Principles of document control
May 5, 2022
What is a Culture of Quality?
May 2, 2022
FAQ
My product is Class I, do I still need a Quality System?
April 21, 2022
Testing, FAQ
Types of verification and validation testing
April 15, 2022
FAQ
How long does it take to get an IRB study approved?
April 14, 2022
Are you a Breakthrough product?
April 11, 2022
Webinar
Crash Course on Medtech Investing for VCs & Angel Investors
April 10, 2022
FAQ
How long does it take to get a medical device approved?
April 6, 2022
FAQ
What is a DHF, and do I need one?
March 29, 2022
FAQ
Is my product a medical device?
March 24, 2022
Key Questions When Developing Software as a Medical Device
March 18, 2022
Compliance
Why Do We Start Compliance Early?
March 17, 2022
FAQ, 3D Printing
3D Printing - Will it Help or Hurt Your Device?
March 7, 2022
On Demand Webinar
Crash Course on Medical Device Compliance
February 17, 2022
Webinar - On Demand
The Compliance Journey, Part 2: Transitioning to Full Compliance
October 26, 2021
Webinar - On Demand
The Compliance Journey, Part 1: Precompliance
September 1, 2021
Compliance, Manufacturing
Managing Quality With a Contract Manufacturer
March 24, 2021
