Medical Device

The Medical Device Industry – The World’s Most Innovative?

Medical technology covers a large variety of products and solutions used in health care, such as radiology and radiotherapy devices, orthopaedic implants, stents, scalpels, walkers, pacemakers, and dialysis machines. All in all, there are approximately 500,000 products worldwide that are all intended to diagnose, treat, or alleviate various diseases.

The so-called medtech industry is extremely innovative and produces more new patents than any other industry. Despite its geographical size, Sweden has created a wide variety of global medical device successes over the years – such as ultrasound, the pacemaker, permobile (powered wheelchair), incubator, and artificial kidney.

From hospital to home

i3tex develops medical devices that are used both within clinical settings and also in the home environment. We work primarily with manufacturers of medical equipment that either need to reinforce the skill set of their own development team – or would like to outsource the responsibility regarding development altogether. Among the examples are:

 Respiratory aids
 Advanced wound care
 Radiation Treatment
 Birth Control
 Hearing aids
 Alarm system

Outsourcing of entire development projects

For those customers who want to outsource the design work to an external party, we can develop solutions containing electronics, software and mechanics. These products may be used for diagnostics, monitoring or treatment. Particularly interesting is the development of connected medical devices and software development >>

We have expertise in the entire development process, from identifying user needs and developing detailed designs for production, certification and approval for different markets.

20 years of well-documented precision

Joint for medical devices are the regulatory requirements that must be met. The purpose is to ensure that patients and users are not exposed to unnecessary risks, which means that all medical technology products must have documentation that proves that the product is safe and complies with laws, standards and safety regulations. The documentation should, among other things, specify the intended use, include requirements, design and manufacturing specifications, risk management and user manuals.

Our product developer complies with standards such as EN ISO 13485 (management system), EN ISO 14971 (risk management), IEC 62366 (usability), IEC 62304 (software lifecycle software) and several of the standards of the IEC 60601-1 series (electrical safety).

Anna Axelsson
Business Unit Manager Medical Device