When an electronic product must meet ATEX, cyber security, medical device or market-specific requirements. Svep can support with design reviews, gap assessments, risk documentation and technical files to ensure that compliance is built into the development process.
The ATEX directives define minimum safety requirements for workplaces and equipment used in explosive atmospheres. The name comes from ATmosphères EXplosibles, French for “explosive atmospheres”.
Svep supports ATEX-related design reviews and has worked with authorities such as EX-Veritas when reviewing products from a design point of view.
Svep identifies security vulnerabilities and compliance gaps in products before they become late-stage redesign issues.
Assessment: detailed reviews of architecture, implementation and documentation to identify regulatory and security gaps.
Analysis: technical recommendations for reducing risk and strengthening product defenses.
Deliverables: reports and actionable remediation steps that support compliance planning and cyber security work.
If you are defining compliance scope for ATEX, cyber security, MDR or a technical file, contact Svep before design freeze. We can review requirements, identify decision points and specify the documentation or tests needed for the next development step.
With Svep, MDR is integrated into the development process. Svep is ISO 13485 certified within the necessary quality systems for MDR development, supporting safety, testing and regulatory requirements for medical devices.
We help product teams navigate medical device regulation and prepare the documentation needed for review and development decisions.
Svep helps establish technical files for electronic products in relation to relevant directives, standards and regulations. The technical file supports market access, product safety and regulatory review.
We assist with compiling documentation such as design specifications, test reports, risk assessments and other required material.
We also provide support as requirements evolve, helping teams keep documentation aligned with product changes and applicable regulations.
We have created brand new system solutions,
steered ongoing projects back to track,
and developed over a hundred different products over the years,
sold in hundreds of millions of units worldwide.
At Svep, innovation, design, and quality, go hand in hand.
We are your development partner in software and electronics.
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