MEDICINTEKNIK & MEDICINSK IT / DIAGNOSTIKA Sverige/Danmark2012

Regulatory Affairs MDD Classes I-III EU FDA

Prepared for 3rd Edition Standards package EN60601-1? Etteplan advise customers on these matters as well as: Regulatory Strategy, Regulatory Affairs MDD Classes I-III EU FDA, CE marking, 510K, Quality systems, Submissions and training. Start-ups and large corporations benefit from our knowledgeable staff and flexible solutions. Etteplan is ISO13485 certified.

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Project Management

Good communication is a key element to reaching project goals. Our qualified medtech project managers are assigned by companies to drive projects and deliver results. This is done according to the ISO13485 standard. Our project manager are assigned to design & development of project in all MDD Classes I-III EU FDA.

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Usability Engineering

Usability is key to the user, market acceptance and approval. Companies assign our usability engineers before, during and after development to ensure products meet customer needs.
Our qualified engineers are assigned to collect User needs, Ergonomic, HCI, MMI, Anatomy, Physiology and Anthropometric data for the design and development of equipment.

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Industrial Design

“Medical goes consumer” is an ongoing trend within the medtech industry. Patients are treated more and more as customers and have the ability to choose a medical device as well as being responsible to operate it. This trend drives the need for a new approach to product development, where industrial design and usability are key drivers.

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Hardware/Software Development

Products that are inuitive and effective are sought after in medtech markets worldwide. Companies have assigned our hardware/software engineering staff to develop solutions for the clinical and home setting. Analogue, Digital and Wireless design.

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Technical Documentation

From the creation of design input to design transfer, Etteplan offers the support you need to build Quality Management Systems, Technical Files and History Files to meet regulatory requirments. Furthermore, Etteplan offers a one-stop-shop for technical documentation, ie Simplified Technical English, Technical Translations, Technical Illustrations and software to effciently create, manage and publish technical information.

Mechanical Engineering

The good performance of medtech equipment is essential. Customers have assigned our Mechanical Engineers to develop solutions from heavy duty rehab products to fine highly detailed surgical instruments and implants. We work in all MDD Classes I-III EU FDA. Our facilities give customers access to rapid prototyping, scale models, prototypes, CAD and documentation.

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Innovation Workshops

A tried and proven method to ideate and find solutions. Innovation Workshops are held in purpose built facilities to help your team uncover new product ideas. For more information, ask our workshop facilitator at Booth C:06.