MedTech Week Magazine 2019 At a glance

Highlights from the 5th Edition of the Award-Winning MedTech Week Magazine

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I am particularly pleased to see so many examples of companies reaching out to their communities and engaging with employees – after all, medtech is really about people rather than technology.

Serge Bernasconi
Chief Executive, MedTech Europe
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22

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51

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Involved

55

External
Partners

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Perspectives

Perspectives New role for Clinical Research Organisations
Regulations and legal, Expert

New role for Clinical Research Organisations

Two new EU Regulations will require the collection and analysis of more data during clinical investigations

Perspectives Green is the new black
Value of medtech, Expert

Green is the new black

Climate action is rightfully gaining space on the policy agenda. Healthcare is part of the problem and must become part of the solution.

Perspectives Improving the lives of people living with diabetes
Diabetes, Expert

Improving the lives of people living with diabetes

It is incredible when I think that nearly 100 years have passed since the discovery of insulin. Since then, insulin has saved the lives of millions of people living with diabetes around the world.

Perspectives What do patients want
Diagnostics, Expert

What do patients want?

Patients don’t care about technology – they care about the quality of life

Perspectives Career inspiration My journey in biomedical engineering
Career and education, Expert

Career inspiration: My journey to biomedical engineering

At the age of seventeen, I was good at maths and sciences, but I did not know what to study after secondary school.

Perspectives Are you ready for Eudamed
Regulations and legal, Expert

Are you ready for Eudamed?

One of the biggest changes on the healthcare horizon will be new EU requirements for product information. If you are not already preparing for this, start now – the clock is ticking.

Perspectives Changing health changing lives
Value of medtech, Expert

Changing health, changing lives

Our sector has changed a great deal in the last decade, but there is much more innovation to come – notably in customisation and data.

Perspectives Incontinence  Breaking the taboo
Value of medtech, Expert

Incontinence: Breaking the taboo

The condition can be treated, often cured, and always managed

Perspectives Will it make the boat go faster
Value of medtech, Expert

‘Will it make the boat go faster?’

We need to work in partnership with healthcare providers to understand the true value of technologies.

Perspectives The future of medicine is personal
Value of medtech, Expert

The future of medicine is personal

We must all play our part in embedding personalised medicine into Europe’s healthcare systems

Patient Safety First

National associations help companies deliver products of the highest quality

Many medical technologies require a CE mark if they are to be sold and used in Europe. However, for some types of products, there are additional safety standards needed in order to ensure the highest level of security and performance.

Electrical medical devices and systems – everything from x-ray and MRI machines to infant incubators and cardiac defibrillators – are subject to a special series of technical standards for safety and performance. Known as the EN 60601 series, these technical specifications are published by the International Electrotechnical Commission (IEC).

Most citizens can take comfort from knowing that electrical medical devices meet these standards, without having to get too deep into the detail of what lies beneath. For medical technology industry experts, however, diving into the detail is an essential part of the job.

To help improve awareness within the industry of medical technologies and their regulatory complexity, Medicoindustrien hosted a training event in Denmark. The course was delivered by Yannick Charrotton, CTO and co-founder LHS-Lambda Health System SA.

It explained the EN 60601 series, as well as how to use and interpret it. The course also covered how the standard fits into the regulatory environment in Europe and in other markets. Hands-on training sessions were a strong feature of the event which took a practical approach to this complex topic.

The initiative was designed for manufacturers, product development engineers, hospital engineers, regulatory affairs managers, project managers and quality managers. Seven people from four medtech companies took part. ‘It was a great overview from a great teacher,’ said one of the participants. ‘He was very engaged and knowledgeable, listing and making the course relevant for our types of products.’

The course is just one example of how national medtech associations support their members in delivering technologies of the highest standard for the European market: They worry about standards so patients don’t have to.

Country

Denmark

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