93/42/EEC – Technical Documentation
This training provides participants with the understanding of the purpose and requirements of Directive 93/42/EEC, as amended by Directive 2007/47/EEC, in order to familiarize quality and regulatory professionals, engineers, supervisors and management with the technical documentation requirements.
Upon completion of this training delegates will be able to:
- Understand the technical documentation requirements of Medical Device Directive 93/42/EEC
- Prepare technical documentation to meet the requirements of the Medical Device Directive 93/42/EEC
- Use the references and guidance documents available to further enhance their understanding of the documentation requirements
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