Konuslt medicinteknik Fjord Consulting

Product Development

Project management

Project management is extremely important if a project is to be successful. A plan; including activities, time and resources requirements, deliverables such as milestones; that all are realistic and accepted by management and resources involved, is the base for a successful project. Regular follow-up and feedback creates involvement and leads the project forward.

Fjord Consulting can lead your project or support your current project leader. We work according to “Design Control” structure and terminology, ensuring ISO 13485 and 21 QSR part 820 fulfilment.

Risk management

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 life time of the product.

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

Usability/Human factors

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.

Biocompatibility

Biocompatibility studies are performed in order to ensure that device does not contain any substances that are toxic to the patient or user.

Fjord Consulting assists in planning and executing your biocompatibility studies in accordance to ISO 10993.

Clinical evaluation

Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. Clinical evaluation is an ongoing process that is to be conducted throughout the life cycle of the medical device. This information should be used to improve your current and future products. For medical devices it is a regulatory requirement to compile a clinical evaluation report.

Fjord Consulting can support you in clinical evaluation research as well compiling the clinical evaluation report.

Technical documentation

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.