Medical devices

Education

Fulfilling the requirements of CE marking is inconceivable without acquiring the appropriate knowledge. We provide training in all relevant areas related to CE marking of medical devices in the form that best suits your needs: open and outsourced or custom- ized training.

Standard, legislation, guidance

Description

ISO 13485

Standard introductory training

ISO 9001, ISO 14001

Standard introductory training

ISO 13485

Internal Auditor Training

ISO 9001, ISO 14001

Internal Auditor Training

MDR II., III.

Technical documentation

MDR 15.

Person Responsible for Regulatory Compliance (PRRC)

MDR XIV.

Clinical Evaluation

MDR III.

Post-market surveillance system (PMS)

MDR XIV. B.

Post-market clinical follow-up (PMCF)

MDR/IVDR

Cybersecurity

ISO 14971

Risk management

EN 62366-1

Usability Engineering

EN 60601-1

Safety test of medical electrical equipment

EN 61010-1

Electrical equipment for measurement, control, and laboratory use

EN 61010-2-101

In vitro diagnostics (IVD) medical equipment

2006/42/EC

CE marking of machines

2006/42/EC

EN ISO 10218-X

ISO/TS 15066

CE marking of industrial robot and collaborative robot systems

EN ISO 12100

Risk evaluation of industrial machines

(relevant standards)

Safety and technical requirements of machines

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