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Services in the field of Medical Devices Regulation. Goal is to offer you our best knowledge and registration service, not limited only to EU, FDA and HC regions.

EMC consulting services are also available with number of years experience!

+358 408 271 298

Information

Let's check if your device is a medical device in your market area.

If your device is the medical device, let's check possible classification and other conditions to meet the requirements.

Registration services are available!

Key expertise area box

EU: MDR 745/2017

USA: FDA CFR 21 §820

Canada: HC SOR/98-282

Quality Systems: ISO 13485

Risk management: ISO 14971

Basic safety and EP: IEC 60601-1

EMC: IEC 60601-1-2

Other world-wide Regulations&Standards

Audits

Who is Jouni Karkinen behind Karkinen.com?

Experience from Datex Div, Instrumentarium Corp

Experience from GE Healthcare

Experience  from Philips

Experience from KaVo Kerr

Contact information

Over 20 years of experience in Medical field.

Please, contact with this form or send an email to info@karkinen.com

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Who is Jouni Karkinen behind Karkinen.com?

My background starts with medical devices in 1992 when Instrumentarium Corp, Datex division hired me.

My experise was needed to understand impact from EU EMC directive to medical devcies.

Later, I was able to help the company, among others, with telemetry ECG, networked patient monitors, product recalls and device registrations.

The company was aquired by GE Healthcare in 2003.

I was hired by Philips Healthcare in 2012.

At Philips I had priviledge to work with a talented R&D team developing high-intensity focused ultrasound, HIFU, device. I was responsible to all regulatory work around it.

In 2014 I moved to KaVo Kerr to help dental x-ray device registrations. I also had a great role to help R&D designers to understand regulations and standards and help them to meet the requirements in early product development phases.