Quality Management Systems (QMS)
Customizing Your Framework For Operational Reality
We specialize in adapting, maintaining, and refining your existing QMS to integrate new technologies and ensure continuous compliance with the ISO 13485 standard.

A Highly Customized System that Fits Your Technology

A certified QMS is the backbone of your compliance, but it is never static. Your QMS must constantly evolve to keep pace with internal and external drivers of change. Whether triggered by shifts in regulation, new products, or new manufacturing procedures, failure to adapt your QMS introduces regulatory gaps and operational friction. We ensure your QMS remains lean, efficient, and technologically integrated, reflecting the reality of your unique manufacturing environment.

„We don't create generic manuals, but procedures that fit the company’s way of working. Our goal is a lean, flexible QMS that is technologically integrated and better accepted by staff because it actually supports their daily work.“
— Carolina Salenius, Senior Consultant
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

Continuous Conformity and Technological Integration

Validation demands empirical evidence that equipment and processes consistently meet specifications. Our value lies in highly customized work that adapts your system for specific, non-standard technological requirements.
  • 1.
    Technology Adaption and Integration
    We develop and implement new procedures and work instructions to integrate new products, manufacturing processes, or technologies into your existing QMS structure.
  • 2.
    QMS Maintenance and Audit Preparation
    We support the maintenance of your certified system, including providing expertise for internal and external audit preparation.
  • 3.
    Revalidation and Periodic Review
    We ensure your system remains validated over time by managing scheduled Revalidation activities and performing Periodic Reviews of processes and documentation.
  • 4.
    Regulatory Change Management
    We identify potential impacts and adapt your QMS to ensure compliance with updated regulations and standards or specific requirements that affect your processes.
    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