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Compliance & Quality Policy

Quality and Regulatory Commitment

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At I.S.E. S.r.l. ("ISE"), compliance is central to how we design, manufacture, and support our in vitro diagnostic (IVD) medical devices. We carry out our business in a manner that will:

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  • Meet or exceed the requirements, needs, and expectations, explicit and implicit, of our customers;

  • Conform with Directive 98/79/EC (IVDD), Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 (IVDR), ISO 13485:2016 (A11:2021), ISO 9001:2015, and the sector-specific systems standards and applicable law in the countries where we operate;

  • Contribute to the continuous improvement of internal performance and the effectiveness of our management system through systematic risk management, applied to reduce risk to a minimum. A risk policy proportionate to the hazard level of each product safeguards the safety and health of end users and patients, while maintaining a high level of product quality and safety;

  • Allocate the resources necessary to achieve our established quality and regulatory objectives.

 

Certified Quality Management System

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I.S.E. holds certification to:

  • ISO 9001:2015 - the international standard for quality management systems.

  • ISO 13485:2016 (A11:2021) - the standard for quality management systems specific to medical devices, governing the full product lifecycle from design and development through post-market surveillance.

 

Regulatory Framework

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Our products and processes are developed and maintained in conformity with:

  • Directive 98/79/EC (IVDD) and Regulation (EU) 2017/746 (IVDR) — the European regulatory frameworks governing in vitro diagnostic medical devices.

  • CE marking requirements, confirming conformity with the applicable European safety and performance standards.

 

Risk Management

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Risk management is embedded throughout our quality system, proportionate to the level of hazard associated with each product. This approach safeguards the safety and health of patients and end users while upholding rigorous standards of product quality and reliability.

 

Continuous Improvement

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We are committed to the ongoing improvement of our internal performance and management system, supported by the resources necessary to meet our quality and regulatory objectives.

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* For compliance documentation, certificates, or regulatory inquiries, please contact our team.

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