THE solution for your regulatory and standards monitoring 

Do not spend time looking for information. Simple, comprehensive and up-to-date, Nex'inform is action-oriented to allow you to focus on the essentials: decisions and actions. No forgetting, no noise. You define with our team immediately the regulations that apply to you and you receive each quarter the information you need for your business.

A summary presentation and detailed gap analysis allow you to both manage your business and to meet the expectations of notified bodies.

With Nex'Inform, get effective regulatory and standards monitoring with minimal resources.

Each quarter, capture the full benefits

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Follow only the texts applicable to your products and your business

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Receive a summary report of developments and a detailed summary of the actions to be taken with gap analysis

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Receive a monitoring report each quarter, without the risk of forgetting

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Use immediately your report in your management review

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A complete solution that meets the needs of certifiers

Why we created Nex’inform?

In a regulatory environment that is becoming more and more drastic, understanding its world is a major asset to anticipate risks and detect opportunities. The main difficulty is the constant evolution of the standards and regulatory environment, new guides published regularly and the quantity of texts relating to medical devices. This task can then be difficult to achieve internally due to lack of time or resources.

By creating nex'infrom, we wanted to make life easier for businesses by allowing them to focus again more effectively on their activities. Information provided is selected, decoded, analysed and used directly because it is customised.

Achieving standards and regulatory monitoring is not only part of the mandatory requirements, but a powerful business management tool. Indeed, it offers time to anticipate regulatory changes and thus make the right decisions at the right time to be sure to maintain safe, efficient and effective products on the market.

Effective regulatory monitoring is the assurance of being one step ahead and being able to work calmly.

Decree No. 2016-1716 relating to the medical device characteristics summary

Annulment of Decree No. 2016-1716 that was published in the Official Journal of the French Republic on December 13th 2016

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How to prepare for the DuPont Transition Tyvek

The transition from Legacy Tyvek® to Transition Tyvek® will take longer than planned. This means that manufacturers will have more time to...

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MedTech Summit : 19-23 June 2017 in AMSTERDAM

nexialist is at the MedTech Summit : 19-23 June 2017 in AMSTERDAM

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