The purpose of this training is to clarify the requirements of the 93/42 EEC Certification Medical Device Directive and share information on how these requirements should be met. The training will be done through example documents and records. Contact us for more information on 93/42 EEC Certificate…
Content of 93/42 EEC Certificate Directive Briefing and Documentation Training
What is a medical device?
What are the Conformity Assessment Routes?
What are the product risk classes?
What should be in the product’s technical file?
Who Should Join to 93/42 EEC Standard Directive Training?
Employees of quality, top management, production, design and development departments
ISO 13485 Standard Internal Audit Candidates
93/42 EEC Medical Device Directive Training Certification
Each candidate will receive a “93/42 EEC Medical Device Directive Informational Training Participation Certificate”.