FDA Submission Types, Costs and Timeframes – Which is Right for You?

It's so easy to remain in an extended state of denial these days. 😒 COVID continues to wreak havoc on your go to market

Heads up, regulatory peeps. The Notified Bodies may flag a product's IFU for 𝙣𝙤𝙩 𝙬𝙖𝙧𝙣𝙞𝙣𝙜 𝙖𝙜𝙖𝙞𝙣𝙨𝙩 𝙩𝙝𝙚 𝙪𝙨𝙚 𝙤𝙛 𝙡𝙖𝙩𝙚𝙭

In The Matrix, Keanu Reeves is offered the choice between a red pill and a blue pill. 💊 The red pill represents

Just when you thought it might be safe to go back to your normal regulatory process. 😲  

Baptism by fire gets a bad rap, and rightly so. It can be a very stressful and ineffective way to learn the ropes of a

The one-year delay in #MDR implementation was mostly a blessing, giving companies additional time to navigate the

I posted about the costs of MDR certification last year, and warned companies that achieving certification would be a

The advertising is what gets them - almost every time, without fail. Many mask manufacturers don't consider their

"If the public knew how insecure so much of the equipment is out there, they would lose their faith in the medical