Our Standards, Certified Excellence
Every Regenyal device is born from a certified, controlled manufacturing process that complies with international standards. Quality is not just a promise; it is a responsibility we honour with transparency, rigour, and traceability.
Our certifications guarantee that every stage – from the selection of raw materials to the final product – meets the highest requirements in terms of safety, efficacy, and reliability. Certification is our way of demonstrating our daily commitment to patients and professionals.
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ISO 9001.
Quality Management System
The ISO 9001 certification attests that the Regenyal Laboratories quality management system complies with the standard for the scope of application concerning the design and production of sterile injectable intradermal and intra-articular medical devices, both for its own brand and on behalf of third parties. This standard certifies that the corporate organisation is appropriately managed and oriented towards continuous improvement and process optimisation.
ISO 13485.
Quality for medical devices
The ISO 13485 certification attests that the quality management system of Regenyal Laboratories complies with the standard for the scope of application regarding the design, manufacture, and commercialisation of sterile injectable intradermal and intra-articular medical devices, both for its own brand and on behalf of third parties. This standard, specific to companies operating in the medical device sector, further certifies that the entire corporate organisation is managed and oriented towards continuous improvement and process optimisation, ensuring compliance with regulatory and customer requirements and reinforcing the company’s commitment to the safety and quality of the medical devices produced.
Certifications of Environmental Commitment
Regenyal promotes a sustainable production model, reducing environmental impact at every stage of the product life cycle. Our environmental certifications testify to the adoption of eco-compatible practices, from material selection to disposal processes.
Environmental consideration is also reflected in the technologies used, packaging, and waste reduction. We invest in solutions that protect the health of the planet, as the well-being of individuals is inseparable from that of the ecosystem in which they live.
ISO 14001.
Environmental Management for Organisations
The ISO 14001 certification attests that the Regenyal Laboratories environmental management system complies with the standard for the scope of application concerning the design and production of sterile injectable intradermal and intra-articular medical devices, for both its own brand and for third parties. This standard certifies that the corporate organisation manages and controls the environmental aspects related to the design and production of its medical devices, with the aim of minimising environmental impact. In compliance with this standard, the company adopts an environmental policy and defines objectives aimed at improving environmental performance and ensuring compliance with legal obligations.
CE Certification.
European safety and compliance
The CE marking certifies the conformity of Regenyal devices with European requirements for safety, performance, and quality, authorising their commercialisation.
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