In this practice-oriented ISO 13485 basic course, you will receive all the relevant information about the most important standard in medical technology: clear, with many examples, and tailored to your company’s needs. Your trainer, DI Martin Schmid brings experience from a wide range of medical technology companies, having supported the implementation of ISO 13485 for more than 20 years.
The seminar contents
The standard ISO 13485:2016
- The European Regulations MDR-IVDR
- Origin and scope of ISO 13485:2016
- Management responsibility
- Responsibility, authority, and communication
- Resource management, training
- Planning of product realization
- Development and design transfer
- Interfaces to risk management
- Procurement: Suppliers and Outsourced Processes
- Production and service provision
- Measurement, analysis, and improvement
Costs
1 day in-house training: € 3,890 (excl. VAT) for max. 10 participants
incl. seminar documents and certificate of attendance, plus travel expenses
your trainer
DI Martin Schmid, Managing Director & Senior Consultant en.co.tec
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
