Design transfer / Production & process control

  • Manufacturing specifications writing DMR

  • Requirements definition to ensure process control

  • Adequate supplier(s) selection

  • Process changes – impact analysis and actions follow up

Process validation

  • Existing validation files review

  • Validation strategy definition (VMP)

  • IQ/OQ/PQ protocols and reports writing

  • Laboratories selection and follow up

  • Statistical techniques

  • Machining, coating, marking, cleaning, packaging, sterilization, … validations

Reference documents

  • MDR 2017/45 & 21 CFR part 820 

  • ISO 13485

  • ISO 10993-x, ISO 19227, ISO 11137, ISO 17737, ISO 11607, ISO 13779, ISO 13179, ISO 17664, ISO 17665, ASTM A380, ASTM A967, ASTM F86, ASTM F2129, ASTM F1580, ASTM F1185, ASTM F1854, ASTM F1147, ASTM 2102

DEM CONSEIL

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75015 PARIS

email : contact@demconseil.com

Tel : +33 (0)7 69 38 30 05 

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