Bioelectronics Corp (BIEL)

[GetSeriousOK]

That's all about a class project done by a Regulatory Affairs graduate student. She did all the work. Looks good on her resume -- "Project Lead at Bioelectronics Corp."

She's not a Doctor -- she's a pharmacist. She's a "PharmD graduate currently pursuing Master of Science in Regulatory Affairs at Northeastern University while working as a Regulatory Affairs intern with a relentless commitment to advancing global healthcare standards."

BIEL didn't do anything. Giving BIEL credit for "checking all the boxes" as a result of this class project is like giving BIEL credit for Ilfeld's research.

Here's what the grad student said on her resume:

* Spearheaded the creation of a comprehensive Standard Operating Procedure (SOP) for Unique Device Identification (UDI) tailored to Class IIa medical devices in compliance with upcoming EU MDR regulations.

• Facilitated the transition of medical devices from MDD (Medical Devices Directive) to MDR (Medical Devices Regulation), ensuring alignment with enhanced regulatory requirements and maintaining "legacy device" status until 2028.

BIEL's devices already had "legacy device status until 2028." This is resume business-speak. It makes it sound like there's nothing left to be done in order for ActiPatch and RecoveryRx to meet all the MDR requirements in 2028. Did you read those requirements?