ISO 14971:2012 Gap Analysis

  • Our team of SMEs worked for the biggest companies and market leaders like J&J, ZimmerBiomet, Novartis, Merck, Roche and others providing support on huge Risk Management and DHF remediation projects and on new product development projects.

    We take now this experience to our clients that are ranging from small start-up looking to place a device on the market with the aid of a supportive and capable product development process to big market leaders and Fortune 500 looking to improve their current process or remediate their existing RMF/DHF.

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    RISK MANAGEMENT PROCESS

    Risk Management is a critical process for the compliance of a medical device or a combination product to the international regulation and standards.

    Nevertheless Risk Management process is not only a mandatory requirement for compliance to ISO 14971:2012 but also a tool to guide into development of safer and effective product.

    A proper risk management process is well linked with Design Control activities, Post Market Surveillance, Verification and Validation, Human Factor Engineering and the company ISO 13485 QMS

    We can help your company setting up or improve risk management process in a way that it will be fully compliant to ISO 14971:2012 but also tailored and optimized to your company needs, way of develop the products, interaction within clients and users, better fitted into the Design Control, Human Factor Engineering and PMS Processes.

    RISK MANAGEMENT GAP ANALYSIS

    We will provide a complete gap analysis of your current Risk Management process, this will include:

    • Full review of your Risk Management Procedures, Templates and forms
    • Review of different example of Risk Management Files
    • Alignment on general company needs and focus for legacy and new development in reference to design controls and risk management
    • Full check of the overall ISO 14971:2012 clause and related annexes against your current process and existing risk files
    • Definition of main gaps and priorities, based on compliance gaps or improvement opportunities
    • Review of connection of Risk Management process to Design Control, Post Market Surveillance, Human Factor Engineering, Design Transfer and existing ISO 13485 Quality System

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