• Your technical documentation may need some improvement?

    Diagnosis and support for compliance to (EU) 2017/45

    Request a diagnosis How 50% of your expenses can be financed?
  • Do you need to upgrade some of your skills?

    - Risk Management / ISO14971
    - Establish technical documentation records
    - Manage a medical device development

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  • Bpath offers solutions for driving your developments and maintaining your regulatory compliance, thanks to a pragmatic approach of your situation.

    Approach
  • Independent company supporting project owners in the field of medical devices

    Services
  • Meeting point of several competencies

    Contact

Approach of Medical Devices Projects

Understand each other

Medical Devices related projects require the involvement of multidisciplinary competencies. Establishment of strong relationships is key at each project step.

Think ahead

Various factors that can influence the forecasted results have to be as much as possible identified, either to revise expectation, or change the previously scheduled path.

Act right

Accuracy of the action, by its content and its timing of execution, dedication and enthusiasm while acting, highly influence the outcomes.

Services

Listen to your needs & evaluate the added value we can bring to your projects will be the first step prior to the engagement of the consulting activities. After a first contact, a technical & financial proposal will be established including the approach, the services steps, obligations, means, responsibilities, time and cost. The field of services goes from a single new concept search to an entire project management, all conducted in compliance with Regulation (EU) 2017/745.
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  • Technical and Regulatory records

    General Safety & Performance Requirements [GSPR]
    Summary of Safety and Clinical Performance
    Periodic Safety Update Record [PSUR]
    Instruction for Use [IFU]

  • Technical Documentation Diagnostic

    On a specific topic
    In regards to the (EU) 2017/745 regulation

  • R&D / Technical Documentation

    Conception study, Prototypes, Feasibility
    Verification tests protocols and reports
    Design & Manufacturing Validation
    Overall development management, Design Traceability

  • Risk management

    Risk procedure, plan, analysis and report
    Risk management training / ISO 14971:2019

  • Bibliographic searches and reports

    For State-of-Art establishment and device performances definition
    As part of Clinical Evaluation Report [CER]

  • Post-launch activities

    Change control management
    Complaints, Non-Conformity, CAPAs

  • Responsible resource supporting your organization

    Interim team management
    Person Responsible for Regulatory Compliance [PRRC]

Our Clients are: Medical Devices Manufacturers, Surgeons, New Ideas Owners, Investors