+316 426 418 10

Regulatory Basics of Medical Devices in Europe

Business Development

MODULE REFERENCE

COURSE DESCRIPTION

The workshop conveys basics of medical device regulations in Europa. It addresses the critical topics of classification and conformity assessment in accordance with EU directives and regulations.

**Content:**
- What is a medical device
- Applicable regulations in Europe (directives/regulation)
- National implementation
- Classification and conformity assessment
- Standards
- Jurisdiction in Germany
- Basics of quality management
- Post-market surveillance and vigilance

SHORT REF

BI-06

COMMITMENT

2 x 3.5 hours

COST

3500

DELIVERY / PARTNER / CONTRACTOR

2 x 3.5 hours

MINIMUM CAPACITY

1

MAXIMUM CAPACITY

20

QUANTITY AVAILABLE

2
Interested in this course?
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Contact Us
+316 426 418 10
blockstart.smartservices@brightlands.com
Address
Smedestraat 2
6411CR, Heerlen
The Netherlands
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