Compliance and Regulatory

Our comprehensive compliance and regulatory services to help your business navigate the complex landscape of industry regulations and standards. 

 
Our team of experts is dedicated to ensuring that your products meet all necessary requirements, allowing you to focus on what you do best – delivering high-quality products and services to your customers.
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ATEX Directive

The ATEX directives are two of the EU directives describing the minimum safety requirements for workplaces and equipment used in explosive atmospheres. The name is an initialization of the term ATmosphères EXplosibles (French for ”explosive atmospheres”). We have worked with known authorities such as EX-Veritas when reviewing products from a design point of view.

Cyber Security

We specialize in identifying and addressing security vulnerabilities to ensure your products meet regulatory standards and protect against cyber threats.

Thorough assessment we conduct detailed reviews to identify compliance gaps and security vulnerabilities.

Comprehensive analysis where our experts provide valuable insights and recommendations to fortify your defenses.

Reports and actionable solutions where our clients receive a roadmap for achieving compliance and cybersecurity excellence.

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Industry and market requirements

Get in touch with us to learn more about how we can get you that competitive edge and tick all the boxes needed to excel within industry, market and user needs.

Medical Device Regulation

With Svep, your development process becomes smoother, faster and more reliable. We are certified withing the necessary quality systems for MDR development, ensuring that your medical devices meet all necessary safety, testing, and regulatory requirements. 

Trust us to help you navigate the complexities of the medical device industry, and bring life-saving products to the people who need them most.

Technical File

We offer comprehensive engineering services dedicated to helping you establish a robust technical file for your electronic products;  with relevant directives, standards, and regulations. As it is a crucial aspect of gaining market access, ensuring product safety, and building consumer trust.

We will assist you in compiling all the necessary documentation required for your technical file, including design specifications, test reports, risk assessments, and more.

Our commitment doesn’t end with the creation of your technical file. We offer ongoing support and guidance to ensure that your product remains compliant as regulations evolve.

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Kontakta oss

Vi har skapat helt nya systemlösningar, styrt pågående projekt tillbaka på rätt spår och utvecklat över hundra olika produkter under årens lopp, sålda i hundratals miljoner enheter över hela världen.

På Svep går innovation, design och kvalitet hand i hand.

Vi är din utvecklingspartner inom mjukvara och elektronik.

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