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MDR classification rules explained by Avanti Europe at it's expert consultant team

Classification Rules under the MDR

by AvantiAdmin
September 4, 2020November 17, 2020

understanding the classification rules The Medical Device Regulation (MDR) EU 2017/745 defines in its Annex VIII the classification rules for medical devices. Read here how… Read More »

distance sales online shop medical device explained by Avanti Europe

Selling Medical Devices via an online shop

by AvantiAdmin
August 4, 2020August 4, 2020

what you need to know Nowadays, online shops are a common source for buying all sorts of products and services. Thus, it’s a logical consequence… Read More »

ISO 13485 explained by consultant of Avanti Europe

Who needs to get certified according to ISO 13485

by AvantiAdmin
August 2, 2020January 19, 2021

Do I really need to get certified? Throughout our involved with many manufacturers of medical devices, suppliers, service providers, economic operators and design interested companies,… Read More »

Berater Consultant consultancy consulting

Get the Max out of your consultant

by AvantiAdmin
August 2, 2020August 2, 2020

So you hired a consultant? As you might be excited about the fact of having easily extended the workforce around the hiring freeze, you need… Read More »

Certification of Conformity

by AvantiAdmin
May 4, 2020May 5, 2020

How to identify a original Certification of Compliance The EC Certification of Conformity (CoC) is the formal certification of a Notified Body (NB) in the… Read More »

Declaration of Conformity

by AvantiAdmin
May 4, 2020March 30, 2021

How to establish a compliant declaration of conformity The EC Declaration of Conformity (DoC) is the formal act of a manufacturer to declare that the… Read More »

harmonised and consensus standards

by AvantiAdmin
April 23, 2020March 3, 2021

harmonised standards and consensus standards Developing a medical device will bring you and your team to the terms of harmonised and consensus standards. Read here… Read More »

custom-made vs. off-the-shelf

by AvantiAdmin
April 23, 2020April 23, 2020

What you need to know when manufacturing custom-made medical devices Medical devices, and specifically implants, tend to become more and more patient-specific. Read here what… Read More »

How to best set claims for a medical device

by AvantiAdmin
April 10, 2020April 10, 2020

How to best set claims for a medical device Claims for a regulated product are the promise to the user for its performance, safety and… Read More »

Why choosing a consultant over a regular employee

by AvantiAdmin
April 9, 2020April 10, 2020

why choosing a consultant over a regular employee It is like a constant battle of thoughts. Should a company rather hire a consultant or aim… Read More »