• 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 Medical Devices Directive 93/42/CEE and with Regulation (EU) 2017/745. Please find here examples of currently deliverable service

  • EC Certification

    Updates of Technical Dossier
    Non-Conformity Treatment /N.B.
    Consolidation/Maintenance of Technical Records

  • R&D of new Medical Devices

    Technical file set-up
    Conception study, Prototypes, Feasibility
    Overall development management by design traceability matrix

  • Technical & Regulatory Data Delivery

    Verification ǀ Tests protocols
    Risk management ǀ Regulatory compliance ǀ Usability
    Biological tolerance evaluation
    Design & Manufacturing Validation
    Clinical evaluation (/predicate)

  • Post-launch activities

    Change Control
    Post-market Survey & Clinical follow-up
    Complaints, Non-Conformity, CAPAs

  • New Ideas provider

    New concepts search --
    Intellectual Property (IP) strategy

  • Project Value & Optimization

    Market/Product assessment
    Stages structure & project steps

  • Responsible resource supporting your organization

    Interim team management
    Person responsible for regulatory compliance

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