I will conduct a medical device risk analysis per iso 14971

O
orbivia
O
orbivia
Pierre CHARLIER
conduct a medical device risk analysis per iso 14971
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conduct a medical device risk analysis per iso 14971conduct a medical device risk analysis per iso 14971

About this gig

​Welcome to my Medical Device Risk Management Service!

​Ensuring safety and compliance is critical for market access. I offer professional risk analysis structured strictly according to ISO 14971 to help prepare your Risk Management File for regulatory submissions (CE, FDA).


​What I offer:

  • Hazard Identification: Mapping of potential hazards and hazardous situations.
  • ​Initial Risk Evaluation: Scoring based on Probability & Severity matrices.
  • ​Risk Control Measures: Actionable recommendations to mitigate critical risks (Standard/Premium packages).
  • ​Residual Risk Assessment: Final evaluation post-mitigation.
  • ​FMEA / Risk Matrix: A structured Excel document ready for your Technical File.


​Why choose this gig?

  • ​Methodical approach fully aligned with ISO 14971.
  • ​Clear, professional documentation.
  • ​Tailored to your specific hardware product.


​(Note: For software/cybersecurity analysis per IEC 62304, see the Premium package).

​IMPORTANT: Please message me before ordering to discuss your product and specific needs!

Get to know Pierre CHARLIER

Pierre CHARLIER

Conception produit medical et validation

  • FromFrance
  • Member sinceJul 2025
  • Avg. response time1 hour

  • Languages

    English, French
Ingénieur depuis 10 ans et fondateur d'Orbivia, j'accompagne les entreprises dans le développement de leurs produits électroniques. 🛠️ Pourquoi travailler avec moi ? Mon atelier lillois assure une haute réactivité pour vos itérations : - Électronique : Conception et assemblage sur ma propre ligne CMS. - Mécanique : Impression 3D technique et découpe laser de vos boîtiers. - Tests : Laboratoire interne pour déboguer et valider vos systèmes. - Conformité : Expertise des normes (ISO 13485, 60601-1, 14971, etc.).

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