The Medical Devices Introductory Course 2020

What you will need for EN ISO 13485.6

You will need processes/SOPs for:

Human Resources including training Maintenance and repair of buildings and equipment Health and safety Control of special working environments such as clean rooms Control of contaminated product

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

15

EN ISO 13485.7: Product Realization

7.1 Planning of product realization 7.2 Customer-related processes (must communicate to establish product/service requirements) 7.3 Design and development 7.4 Purchasing (purchased product must conform to specified purchase requirements, suppliers must be evaluated) 7.5 Production and service provision (manufacturing processes must be specified, controlled and validated; product must be identified so that it can be segregated and traced, if necessary) 7.6 Control of monitoring and measuring devices (calibration)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

16