Ce marking: The European Passport Every Manufacturer Needs

I. So, What Exactly Is Ce marking? A. It’s Not Just a Fancy Sticker You’ve probably seen the “CE” mark stamped on everything from phone chargers to medical devices. It’s…

ISO 13485 Certification: What Suppliers & Service Providers Really Need to Know

I. Setting the Scene: Why ISO 13485 Matters (Especially to You) Let’s be real—medical device companies are under pressure. There’s no wiggle room for guesswork when it comes to safety,…