Committed to Quality, Safety & Controlled Manufacturing
At GlobeForge B.V., we apply structured quality and compliance processes for the development and manufacture of assistive and medical-related products.
Medical Device Compliance
Our regulatory workflows are designed around the European medical device framework, ensuring that products entering the market are supported by appropriate documentation and oversight.
MDR-aligned workflows
Development and manufacturing processes are structured in line with the EU Medical Device Regulation (EU 2017/745) where applicable to the product classification.
Technical documentation
Technical files are maintained and updated throughout the product lifecycle to support conformity assessment and traceability.
CE marking where applicable
Products falling within the scope of applicable European directives or regulations carry CE marking based on the relevant conformity route.
Post-market monitoring & complaints
We operate documented post-market monitoring and complaint handling procedures to capture, evaluate, and act on field feedback.
Quality Management
Our quality framework is built around recognised industry standards and the operational discipline expected of a medical-related product manufacturer.
We follow ISO 13485 quality management practices in the development and manufacture of our products.
This guides how we plan, control, document, and continuously improve the activities that affect product quality and patient safety.
- Structured quality procedures covering design, manufacturing, inspection, and release activities.
- Controlled manufacturing workflows with defined inputs, process parameters, and acceptance criteria.
- Supplier and material consistency controls to qualify partners and verify incoming materials against specifications.
- Production quality inspections performed throughout the build and post-processing stages.
- Documented processes ensuring repeatability, traceability, and clear ownership across the organisation.
Traceability & Manufacturing
Additive manufacturing is operated as an industrial production process: controlled, repeatable, and fully documented from raw material to finished device.
Controlled AM workflows
Production is executed on qualified equipment using standardized additive manufacturing settings and validated procedures.
Batch & production traceability
Each production batch is recorded with material, machine, parameter, and operator information to enable end-to-end traceability.
Verification & post-processing
Quality verification is integrated into post-processing so that finished products meet defined dimensional and visual acceptance criteria.
Consistent manufacturing procedures across builds support reproducible product characteristics and reliable supply for our B2B partners.
Product Safety & Risk Management
Safety is built in from the earliest design stages and re-evaluated throughout the product lifecycle.
Risk management during development
Hazards, foreseeable misuse, and use-related risks are identified, evaluated, and mitigated as part of the design process.
User-focused product evaluation
Products are evaluated with the intended user and use environment in mind, including ergonomic and handling considerations.
Design review processes
Structured design reviews and verification activities are documented at defined milestones before product release.
Continuous improvement
Monitoring data, user feedback, and internal findings feed back into product and process improvement actions.
Compliance & B2B Contact
For regulatory, quality, or partnership matters, our team is available to support professional buyers, distributors, and retail partners.
Reach out to us about
- Compliance and regulatory inquiries
- Distributor and reseller requests
- Technical documentation requests
- Partnership and OEM opportunities
Contact GlobeForge B.V.
GlobeForge B.V.Max Planckstraat 4
6716 BE Ede, Nederland
KvK: 98685228Get in touch
Our quality framework continues to evolve alongside the growth of our medical and assistive product portfolio.