Fjord Consulting can lead your project, act as support to your project manager, be QA, or be an "Independent reviewer" in your Design Reviews.

We have solid experience of leading projects and use structure and terminology according to "Design Control". We have competence and experience of medical devices from Class I - III.

Contact us for more information.

To ensure that medical devices are safe, risks related to the use of the device need to be identified and, as far as reasonably possible, be eliminated. Risk analysis should begin early in the development project and be performed throughout the lifetime of the product.

Fjord Consulting can lead or support your risk management work in accordance to ISO 14971.

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Usability is the processes of defining the user requirements, implementing these into a product or service, and following up on the output. By fully understanding the customers and their wants and needs, the possibility of launching a product that satisfies the customer are enhanced. For medical devices it is a regulatory requirements to perform usability studies.

Fjord Consulting can lead or support your usability work, in accordance to IEC 62366 and AAMI/ANSI HE75.

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All development activities, as well input and output related to the medical devices shall be documented, reviewed and approved. This in order to prove that the requirements of relevant directives are fulfilled, and the device is safe.
Documentation generated are then compiled in a Technical File, Design Dossier, DHF, DMR or other structure depending on where the product classification as well as registration requirements.

Fjord Consulting assists in documenting, reviewing and compiling your technical documentation for all medical device classes.

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Helena Hjälmefjord
Tel +46 722 51 08 69
hhj@fjordconsulting.se