Understanding certifications is essential when purchasing or distributing medical equipment. Two of the most important are CE and ISO — but what’s the difference?

1. ✅ CE Certification – Market Access in Europe

The CE mark indicates that a medical device meets the health, safety, and environmental requirements of the European Union.
It’s a legal requirement for selling in Europe.

🔍 Think of CE as a "passport" for your product into the EU market.

2. 🏢 ISO 13485 – Quality Management Standard

ISO 13485 is an international standard focused on the design, development, production, and distribution of medical devices.
It ensures your company follows consistent quality and safety processes.

📦 It’s about how the company builds and manages the product.

3. 🔄 What’s the Difference?

• CE = Compliance with product regulations

• ISO = Compliance with company processes
  You can have ISO without CE, but CE often requires ISO as part of the approval process.

4. ⚖️ Which One Is More Important?

Both are critical.

• If you're importing to Europe, CE is mandatory.

• If you're working with global distributors or healthcare facilities, ISO boosts credibility and trust.

5. 📌 Always Check the Certificates

When buying a device, ask for:

• CE Declaration of Conformity

• ISO 13485 Certification (from the manufacturer or supplier)
  This helps you avoid counterfeit or unverified products.

💬 In short:
CE tells you the product is legally safe.
ISO tells you the company knows how to make it right — every time.