Legal Manufacturers & Developers
Ensuring Predictable Output Across Your Program
We simplify the complexity of integrating external partners by providing expert structure and communication, accelerating product transfer, and minimizing validation effort.

Delegation and Predictability for Core Development

As the developer and distributor for medical devices or in vitro diagnostics, you carry the ultimate regulatory responsibility, but your control is fragmented across external partners. Forcentis acts as your operational arm, focusing on mitigating supply-chain risks and delivering predictable output. We take ownership of external coordination, freeing up your team for core development activities and securing your launch schedule.

Our Approach

Focused Services for Supply Chain Predictability

We offer focused support to transform your outsourced project into an efficient, reliable, and profitable program, ensuring every supplier interaction contributes to your schedule certainty and compliance.
  • 1.
    Supplier Preparation & Risk
    We mitigate initial risks and budgeting difficulties by providing complete and precise information for suppliers and executing early identification and assessment of process and supply-chain risks.
  • 2.
    Validation & Schedule Reliability
    We secure the necessary product supply and ensure your team focuses on core tasks by coordinating supplier process validation and ensuring timely provision of products for internal studies.
  • 3.
    Supplier Transition Management
    We manage complex supplier changes and free up your internal team by coordinating project management in establishing a new supplier and organizing the transfer of existing systems and processes between suppliers.
  • 4.
    Manufacturer Evaluation
    We provide a better supplier selection basis by conducting upfront evaluations of new manufacturers against regulatory requirements and technical criteria, ensuring long-term fitness for purpose.
    „Our primary job is to secure the external product supply and validation activities. By taking on the demanding coordination tasks, we ensure the LM's internal team can focus 100% on their core design and market launch activities, securing maximum efficiency and schedule reliability.“
    — Carolina Salenius, Senior Consultant
    Service and Value

    Our Commitment to Your Success

    Complex supply chains and stringent customer demands require precise execution. We provide the expert guidance to handle all regulatory requirements, ensuring your contractual commitment is secure and profitable.

    • Our Service

      Comprehensive and accurate specifications for suppliers

      Your Benefit

      Reliable, more comparable quotations, minimization of project risks

    • Our Service

      Supply-chain and process risk assessments

      Your Benefit

      Early risk mitigation, fewer delays, and less budget overruns

    • Our Service

      Coordination of process validation at suppliers

      Your Benefit

      Less effort for your team, more time for internal development

    • Our Service

      Timely provision of products for design verification, design validation, and stability studies

      Your Benefit

      Easier planning and higher schedule reliability

    • Our Service

      Project management for establishing a new supplier

      Your Benefit

      Free up more resources for your core activities prior to market launch

    • Our Service

      Evaluation of new manufacturers

      Your Benefit

      A better basis for supplier selection

    • Our Service

      Organization of the transfer of existing systems and processes from one supplier to another

      Your Benefit

      Shorter interruptions and simplified project planning

    Roles

    Expertise for Every Step of your Project

    Whether your needs are strategic, advisory, or hands-on operational, Forcentis takes on the exact role required for your project’s success.

    Project Management

    We take full ownership of project planning, coordination, and communication. This ensures transparent processes, efficient execution, and complete traceability from concept until final validation.

    Consulting

    We provide strategic and technical advice on regulatory, technical, and organizational matters. This allows us to deliver structure and regulatory certainty to complex processes and challenging situations.

    Implementation

    We provide hands-on support for the implementation, documentation, and execution of tests, validations, and processes. Our pragmatic, solution-oriented approach keeps us close to your operational environment and project goals.