Requirements Management
Translating Vision into Verifiable Specifications
We mitigate ambiguity in your project’s foundation, ensuring your specifications are verifiable, traceable, and compliant with global medical device regulations.

The Foundation of Compliance and Quality

Every successful project begins with a robust and precise definition of requirements. Yet, translating high-level needs into clear, actionable technical specifications is a complex and often ambiguous challenge that can jeopardize regulatory compliance and manufacturing efficiency. Forcentis acts as your regulatory and engineering-driven partner, ensuring that requirements are correctly transferred between organizations and from product specification to manufacturing instructions. We build a secure foundation that guarantees predictability throughout your product’s lifecycle.

„In medical devices manufacturing, the friction almost always starts at the specifications. We don't just write requirements; we use our market insight to ensure those requirements are technically achievable and protect both the manufacturer and the recipient from unfulfillable obligations.“
— Michael Roth, CEO
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.

Our Methodology

Securing the Project's Foundation

Requirements Management is the critical first step where accuracy and comprehensiveness dictate future compliance. We offer hands-on expertise to eliminate ambiguities and ensure your core specifications are verifiable, protecting your project from future regulatory and commercial risk.
  • 1.
    Specification Analysis & Review
    We critically analyze and review your existing requirements to ensure they are complete, testable, and logically sound. Our interdisciplinary experience allows us to identify inconsistencies, ambiguities, or technical specifications that are difficult or impossible to fulfill in the manufacturing process. This proactive review provides the certainty needed to prevent costly downstream issues and contract disputes.
  • 2.
    User Requirements Specification (URS)
    We take on the hands-on task of writing or adapting high-level user requirements specifications (URS) and functional specifications within your quality management system (QMS). Our focus is to translate requirements into clear technical specifications that serve as a robust foundation for equipment design and process development.
  • 3.
    Mediation and Requirement Redefinition
    When customer requirements appear unfeasible, we mediate between parties to understand the underlying intent, enabling a mutually agreeable redefinition that is both achievable and fully compliant with product standards.
  • 4.
    Traceability and Compliance Tables
    Establishing full traceability of requirements is mandatory for every medical device. We create and maintain the necessary traceability tables to guarantee that all specifications are fully implemented and that testing is exclusively focused on what is truly required.
  • 5.
    Design Transfer and Documentation
    Design transfer is the critical handover of the product design into the manufacturing specification. We provide expert guidance to secure this transition, ensuring seamless and accurate implementation of product specifications into production documents and quality procedures.
    Expert Perspectives

    Regulatory Insights & Knowledge

    Stay up-to-date with the regulatory landscape and gain practical knowledge from our specialists on critical topics spanning validation, implementation strategy, and compliance.
    Questions

    Answers to frequently asked questions

    Would you like to know how we work? Here you'll find answers about our methods and processes.

    It is important to know the type and scope of the audit. Will the audit be conducted by a customer or a certification body? Which norms and standards will be checked for compliance? Which parts of the business will be audited, and will it be a system or process audit? Is there an audit plan?

    Once all this information is available, targeted preparation can begin. It is important to ensure that everyone required for the audit is available and that the required documentation is up-to-date and accessible. Responsibilities must be defined; the responsible persons should be familiar with their processes and instructed on appropriate conduct during audits.

    Revalidation of a manufacturing process may be necessary for various reasons. Regulatory requirements may change and require revalidation. Furthermore, changes to or tightening of product specifications may necessitate revalidation if the existing validation does not sufficiently demonstrate compliance with the changed specifications. By far the most common reason for revalidation is changes to the manufacturing process or manufacturing equipment.

    A process window for a manufacturing process is defined during process development. To do this, the critical process parameters affecting product quality must be identified. For process development, a design of experiments (DoE) is recommended, which means that statistical methods are used to plan and evaluate experiments. The result of process development is a set of limits for critical process parameters within which product quality meets the specifications. Proof that product quality meets the specifications within these limits is usually provided during the operational qualification (OQ).

    Process risk analysis considers the entire process flow in the manufacture of a product, from the receipt of raw materials to the dispatch of the product. It focuses on processes, environmental influences, and operator influences, among other factors. A comprehensive process risk analysis can be carried out in a modular fashion and consist of several risk analyses, that focus on specific process groups.

    Equipment risk analysis, on the other hand, considers a specific device or system. Among other things, it considers the function of system components, materials used, wear and tear, settings, and related aspects. In the case of an assembly line, equipment risk analysis also considers the automated assembly process.

    Yes, FAT and SAT can be integrated into the qualification to avoid duplicate testing. It is important that the same documentation requirements are met as those for qualification documents, including the same review process and the same requirements for Good Documentation Practice (GDP). The integration of FAT and SAT into the qualification should be described in the Validation Master Plan (VMP).

    It is important that the production specification goes beyond the geometric product specification (GPS). Other characteristics that should also be specified include:

    • Identification of critical characteristics
    • Definition of the production environment (clean room class)
    • Particular purity requirements
    • Microbial purity requirements
    • Functional requirements
    • Packaging requirements
    • Batch size
    • Labelling requirements
    • Definition of the date of manufacture
    • Quality level for the batch
    • Documentation requirements

    A completed test method validation should be available for operational qualification (OQ) at the latest, as product quality must then be verified at the limits of the process window. However, it is highly recommended to have a robust and reliable method available for process development so that there are no surprises later on because the process development was based on unreliable measurement data.

    The test method validation usually includes a Gauge R&R study.

    Forcentis has established expertise and documented history in validating a wide range of analytical, measuring, and functional tests crucial for quality control in the regulated environment of medical device  and in vitro diagnostics (IVD) industries. These include:

    • Measuring with tactile coordinate measuring machines
    • Measuring with optical coordinate measuring machines
    • Measuring with computer tomographs
    • Automated visual inspection
    • Measuring with probe systems
    • High-voltage tests
    • Tensile and compression tests
    • Functional tests
    • Leak tests
    • Weighing
    • Moisture measurement
    • Manual measuring
    • Visual assessment

    Forcentis has hands-on qualification experience across a broad spectrum of testing and measuring equipment used in regulated medical device manufacturing environment. This includes:

    • Tactile coordinate measuring machines
    • Optical coordinate measuring machines
    • Metrological computer tomography
    • Vision inspection systems
    • Probe systems
    • High-voltage test devices
    • Tensile and compression testing machines
    • Functional testing devices
    • Leak testing devices
    • Scales
    • Analysing instruments

    The manufacturing processes Forcentis has already validated include:

    • Injection moulding
    • Thermoforming
    • Fully automated assembly
    • Manual assembly
    • Inline vision inspection
    • Ultrasonic welding
    • Laser welding
    • Laser marking
    • Pad printing
    • Inkjet printing
    • labelling
    • Corona treatment
    • Gluing
    • Packaging, including in sterile barrier systems in accordance with ISO 11607
    • Granulate conveying
    • Granulate drying
    • Milling
    • Turning
    • Cleaning, cleaning validation
    • Washing
    • Filling
    • Cleanroom operation
    • Transport stability
    • Shelf-life studies

    Forcentis has demonstrated extensive experience in the qualification of a broad range of critical manufacturing equipment and systems used across the medical device and IVD industries. The types of manufacturing equipment for which Forcentis has qualification expertise include:

    • Injection moulding tools
    • Injection moulding machines
    • Thermoforming systems
    • Thermoforming moulds
    • Fully automated assembly lines (cycled, continuous motion, rotary and cam-controlled)
    • Vision control systems
    • Ultrasonic welding systems
    • Laser welding systems
    • Laser printing systems
    • Pad printing devices
    • Inkjet printers
    • Labelling systems
    • Gluing devices
    • Packaging machines, including for sterile barrier systems
    • Granulate conveyor systems
    • Granulate drying systems
    • Milling and turning machines
    • Cleaning and washing machines
    • Filling systems
    • Storage and cold rooms
    • Production rooms
    • Clean rooms (without air classification)
    • Means of transport