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How we work

Our projects are always built on genuine dedication to our customers' products and operations. We follow your innovation process with flexibility and a long-term commitment.

We give you the confidence you need to pursue your ideas and the resources you need to focus on your goals.

How we work within Medical devices

Agile methodology for medical devices

We work with short iterations, allowing you as the customer to continuously provide input while you product is developed and tested. This agile approach operates within a development model structured into phases, with defined templates and methods ensuring that our work and the final product meet the requirements set by standards and regulations. Lifecycle processes such as IEC 62304 and IEC 81001-5-1 are pivotal to what we do.

We integrate all applicable requirements from standards related to risk management, usability, quality systems, and information security.

Knowledge and experience

Working as a business consultant and product developer in medical technology is not just about detailed knowledge of technology, laws, and regulations. Equally important is the experience required to understand industry practices. Experience also brings a valuable network of contacts within the industry.

Responsiveness

One of the key benefits of hiring an external consultant is gaining an outside perspective. However, this requires the consultant to have excellent sensitivity and the ability to truly understand the client’s situation and needs. Therefore, we place great emphasis on building relationships and often work with small, quick changes.

Simplicity

Our clients hire us to make the right decisions in situations where everything needs to align perfectly. This could involve establishing a partnership, launching an innovation, or simplifying a quality system to enable business growth. We always strive to find simple and smart solutions, even when the problem is complex.

Collaborations

Over the years, we have learned that collaboration with others is key to solving complex challenges. We have a broad network of friends and industry colleagues both within and outside Sweden. Together, we can tackle almost any challenge.

Joy of creation

It is fantastic to work as an innovation-supporting consultant. We get to contribute to the development of new and often revolutionary products, and we encounter everyone from passionate pioneers to dynamic development teams. We share an interest in technology, the joy of creation, and the desire to shape the healthcare of tomorrow.

Precision

Everything we do is done with the utmost precision. It is fundamentally a matter of professional pride, but it is also about the added value we bring as consultants. When you bring in a specialist to solve a problem, you should not have to redo the work afterward.