It impacts biotech, MedDev, MedTech, pharmaceuticals, cosmetics, clinical trials, and more. Slows readiness of life-saving products to market.

This will cripple innovation and guarantee that bad actors around the world will continue to sell adulterated drugs and devices into the American market.

Hello World! Specifically #Healthcare #Patients #Doctors #Hospital #Pharma #PharmaTech #insuretech #diagnostics #meddev #VBC #HCLDR #Pinksocks #TheWalkingGallery #MedTech #HealthTech #DigitalHealth #VC #CVC #PE #fund #CrowdValidation #MedMo MD: @alexbfair.bsky.social

It impacts biotech, MedDev, MedTech, pharmaceuticals, cosmetics, clinical trials, and more. Slows readiness of life-saving products to market.

This will cripple innovation and guarantee that bad actors around the world will continue to sell adulterated drugs and devices into the American market.

And hospitals / ASCs serving primarily private insurance populations. And the MDs who are compensated per procedure. MedSchools & PBMs clearly. And the meddev/pharma companies squeaking by FDA approval on at best modest to marginal effects. We shouldn't underestimate how many the system is serving.

i dont need no education
we dont need no thought control
no dark sacasms in the classroom
teacher leave them kids alone
HEY MEDDEV leave the world alone
all in all you just another brick in the wall
youtu.be/YR5ApYxkU-U?...

QmsWrapper isn't 13485-only, you can pick "QMS for MedDev" or "QMS ISO 9001", so it's broader than a MedDev-only tool.

QmsWrapper's setup offers two paths, MedDev and ISO 9001, so mixed manufacturers can match the QMS to the work instead of forcing every process into a 13485-only model. #QMS #ISO9001 #ISO13485
https://qmswrapper.com

The annoying qmsWrapper misconception: it's only a medical-device QMS. You literally choose QMS for MedDev or QMS ISO 9001 at setup. That matters when one quality system serves regulated and non-regulated work. 13485-only thinking leaves useful scope on the table: qmswrapper.com

Why is everyone calling qmsWrapper med-device only? At setup you pick 'QMS for MedDev' or 'QMS ISO 9001', so it runs both. We've wasted audit prep hours because teams assumed 13485 was the only path. Check assumptions before you buy. Anyone else seen this? Qmswrapper.com

Recognizing SA excellence!

MDMSA Chairlady at #AfriSummit, accepting the Partner Support Award from the platform representatives on behalf of MDMSA.

Connect for growth.

👉 www.pharmaregafrisummit.com/meddev/

#MDMSA #AfriSummit #MedTechSA #SelfReliantSA #SAInnovation #Egypt

Africa uniting! 🌍

MDMSA Chairlady connects with industry peers at #AfriSummit to forge an inclusive, self reliant SA economy.

#SAtoAfrica Link:

www.pharmaregafrisummit.com/meddev/

#MDMSA #AfriSummit2025 #AfricanUnity #SAtoAfrica #MedDevices

MDMSA Chairlady on the ground at #AfriSummit!

🎙️ Speaking on Nov 4-5, driving the self-reliant economy narrative.

See her session! www.pharmaregafrisummit.com/meddev/

#MDMSA #AfriSummit #MedTechSA #SouthAfrica #Speaker

Damn it, I just bought a half gallon of milk too. WTF use is the US FDA if they don't look out for the safety of our food? (She says as a person who deals with the FDA daily for MedDev issues.)

youtu.be/IEpAyLutGuk?...

Somebody might ask him what he intends to do if the mob boss in chief starts to implement tariffs on MedDev or Pharma companies he wishes to extort?

I work in meddev/pharma. They make no money from it, so they stifle research. Then, whenever the next pandemic/epidemic manifests, they’ll swoop in with their vaccines full of unethical ingredients, and folks will beg to get it.

Me? I’ll hop to Canada for the best vaccine.

The biggest AI Act challenge isn't documentation.

It's keeping risk, testing, technical documentation, and evidence aligned every time the AI changes.

That's a traceability problem.
qmswrapper.medium.com/the-real-wor...
#EUAIAct #AIAct #regulation #MedDev

Stumbled across Ryuk in class, and now I am so excited to have a malware example that affected Healthcare that isn't just WannaCry! Anyone got a favorite malware that targeted hospitals or insurance companies? I need examples for Meddev companies as to why the FDA cybersecurity are min. Requirements

Building an Open-Source QMS with Little Web Development Experience Why I'm Doing This After years in MedDev and pharmaceutical quality systems, I've watched small and mid-sized companies st...

#opensource #devjournal #discuss #beginners

Origin | Interest | Match