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CE TECH For MDD

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  • Biological Evaluation Report

    Biological Evaluation Report

    £100.00

    This document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations to ensure compliance to ISO 10993-1.

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  • Quality Assurance Plan

    Quality Assurance Plan

    £100.00

    The Quality Assurance plan includes the documentation of the project quality, the responsibilities of the quality activities, regulatory approvals, inspections and test activities and ensuring whether the acceptance criteria have been met.

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  • Shelf Life – Accelerated Aging and Real Time

    Shelf Life – Accelerated Aging and Real Time

    £100.00

    A recommended template which will guide you through the regulatory requirements to fulfil your claims.

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  • Usability Checklist

    Usability Checklist

    £40.00

    The usability checklist is intended to obtain suitable usability of the medical device, by minimising the error and the risk related to the use of the device that are able to be amendable by the manufacturer.

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  • SERVICES
    • REGULATORY AND QUALITY ASSURANCE SERVICES
    • CONSULTANT ON DEMAND
    • MARKET ACCESS, REGULATORY ROADMAP & GRANT-WRITING
    • RESOURCES
    • INTENDED USE STATEMENT
  • TRAINING COURSES
  • SHOP
    • BOOK CONSULTATION
    • TEMPLATES
      • EQUIPMENT VALIDATION
      • MEDICAL DEVICES
      • PHARMACEUTICALS
  • DIGITAL HEALTHCARE
  • NEWS
  • ABOUT
    • ABOUT SIMPLIMEDICA
    • SIMPLIMEDICA PODCASTS
    • INTERNSHIPS
    • SIMPLIMEDICA ON LINKEDIN
    • SIMPLIMEDICA ON YOUTUBE
  • CONTACT