Search F2 TechNotes
Categories
- ASCA Program
- ATEX Directive 2014/34/EU
- CE marking
- Consulting
- EMC Directive 2014/30/EU
- EN 60601-1
- FCC
- FDA
- General Product Safety Directive 2001/95/EC
- IP Testing
- Lasers
- Listing
- Low Voltage Directive 2014/35/EU
- Machinery Directive 2006/42/EC
- Machinery Regulation (EU)2023/1230
- Medical Devices Regulation (EU)2017/745
- PPE Regulation (EU) 2016/425
- Pressure Equipment Directive 2014/68/EU
- Product Testing
- R&TTE Directive 1999/5/EC
- Radio Equipment Directive 2014/53/EU
- REACH
- RoHS Directive 2011/65/EU
- UKCA
- UL 60335-1
- UL 61010-1
- UL 62368-1
- UL 94
-
Recent Posts
Monthly Archives: August 2024
Common Electromagnetic (EM) Emitters
The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic … Continue reading
Posted in CE marking
Comments Off on Common Electromagnetic (EM) Emitters
Easy Approach to Essential Performance in Medical Devices for FDA
F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device. From our experience, the confusion around Essential Performance frequently stems from the fact that what a device manufacturer views … Continue reading
Posted in CE marking
Comments Off on Easy Approach to Essential Performance in Medical Devices for FDA
Environmentally Conscious Design
What exactly is the environmentally conscious design file? You need documentation/policies that show how you are addressing the requirements of that standard. You really should use the standard as guidance (IEC 60601-1-9). Here is some good information on what this … Continue reading
Posted in CE marking
Comments Off on Environmentally Conscious Design