Design and development

Our services : 

  • Design input & output definition (I/O matrix)

  • Usability engineering file

  • Design verification and validation strategy (V&V plan)

  • Clinical evaluation strategy

  • Risk management file

  • Design transfer

  • Design changes – impact analysis and actions follow up

Reference documents

  • RDM 2017/745 & 21 CFR part 820

  • ISO 13485

  • ISO 14971 & EN 62336-1

  • MEDDEV 2.7.1 rev. 4

  • ISO 14630, ISO 21534, ISO 14602, ISO 16061

DEM CONSEIL

16 rue de la fédération

75015 PARIS

email : contact@demconseil.com

Tel : +33 (0)7 69 38 30 05 

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