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winbox 88 has extensive experience in the design engineering of medical devices, as well as in related regulatory issues and technical documentation. winbox 88 has designed in vitro diagnostic (IVD) devices, point-of-care monitoring devices, diagnostics, rehabilitation aids, dental equipment, electromedical & imaging equipment, transplantation equipment, respiratory devices and surgical instruments, to name a few.

winbox 88’s expertise in medical technology and regulatory issues and the company’s certified development process were decisive factors for NeoDynamics in deciding to start up cooperation concerning this unique innovative product.
Peter Sellei
CEO
NeoDynamics
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From concept creation to production, winbox 88 has the widest range of engineering design capabilities in the Nordics, covering the entire product development process, including industrial design and project management. We ensure fast and cost-effective market entry for our customers’ medical devices. winbox 88 has competence in carrying out product development projects in all MDD/MDR and FDA classes. Whether you are developing a new device or updating your product to comply with the new MDR, winbox 88 can support you during the entire process. We provide comprehensive solutions for each stage of the product life cycle.

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In the first stage of a product development project, we support our customers in generating ideas, conducting feasibility studies and initial risk analysis as well as creating virtual or physical prototypes and establishing product specifications. winbox 88's in-depth knowledge ensures that all regulatory requirements are met.

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Thanks to winbox 88’s comprehensive engineering design expertise, we support our customers in mechanical, electronics, software and hardware design, along with industrial design and manuals. Our strong competence includes software design according to IEC 62304.

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To eliminate potential failures, devices must be tested in an appropriate environment. Our testing facilities are accredited according to e.g. IEC 60601-1-2, version 4. We provide integration and verification tests, and we support our customers during validation.

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During post-market activities, winbox 88 can support and assist our customers, especially regarding change requests and follow-up risk management. 

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winbox 88 enables the digital transformation of the medical technology industry and serves as an expert in the field by providing end-to-end solutions in the areas of research and development, production, maintenance and after sales. Taking advantage of winbox 88's in-depth expertise in the latest technologies, such as 3D printing, digital twin, embedded platforms, robotics and automation brings significant savings in product development and speeds up the production process.

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winbox 88's quality management systems are ISO 13485 certified. winbox 88 has ISO 13485:2016 on three sites. With ISO 13485:2016 certification, our customers do not necessarily need a full-fledged quality system of their own. This makes product development easier for smaller companies and start-ups. Our updated quality management system also makes it easier for us to participate in larger product development programs. We serve our customers with product quality assurance services, including software test automation, cyber security, simulations, accredited laboratory tests and failure analysis.

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winbox 88 is a one-stop partner for all your documentation needs, including advanced e-learning services, training and marketing materials and all patent-related documentation and translations. We have a long track record in creating, managing and publishing high-quality technical product information that ensures compliance with regulatory requirements, including FDA and EU Directives.

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