medtech

Medical Device Products

What is a medical device?

In medical devices, there are regulations that define what a medical device is, but in simple terms, a medical device is a product that is used to diagnose and / or treat a patient's diseases or replace the anatomy.

Medical devices are used in all parts of healthcare, but can also be found elsewhere in our society. An example could be our mobile phone which has a function where you can measure your heart rate. Measuring the heart rate is about diagnosing so that function could be a medical device, but it is not really that simple. The function of our mobile phone is often not classified as a medical device because the manufacturer states that it is not intended to be used as such.

How do you know if it is a medical device?

First, the manufacturer must read the regulations and the definition and decide what the intended use is for the product. In the next step, the manufacturer must state this in his documentation about the product, the user must be able to read the instructions for use for the intended use.

Some examples of products classified as medical devices range from compresses, contact lens products, syringes, needles, infusion tubes and pumps for drug administration to X-ray equipment and hearing aids. There are also medical devices that are used by individuals for self-care and as aids in everyday life. Now a days, information systems and software that handle information about the patient are also classified as medical devices.

Healthcare is a technology-intensive business and medical devices are a prerequisite for modern healthcare. The use of these products requires knowledge of their functioning. Knowledge is also required about the risks associated with their use and management, as well as the environment required for a product to be safe.

Jörgen Simonsson - Segment Lead Medical Device Development
Jörgen Simonsson
Segment Lead Medical Device Development

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Karolina Odeblad - Section Manager Product Development
Karolina Odeblad
Section Manager Product Development

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AFRY is committed to protecting your privacy and keeping your personal data secure. We process personal data in accordance with the applicable laws, regulations and our privacy policy.

Henrik Anderson - Section Manager, Medical Device Development Stockholm
Henrik Anderson
Section Manager, Medical Device Development Stockholm

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Contact Henrik Anderson

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AFRY is committed to protecting your privacy and keeping your personal data secure. We process personal data in accordance with the applicable laws, regulations and our privacy policy.