Regulatory Standards
Compliance statements for Pyramid products and software.
Quality Management System & Regulatory Standards
Pyramid puts the quality of what we do first, we uphold the following ISO certifications to ensure that our products are developed and manufactured with care under our QMS.
Download our certificates:
ISO 9001:2015 - Certificate No. FM 591212
ISO 13485:2016 - Certificate No. FM 637614
Pyramid products are CE marked for compliance with the Low-voltage and Machinery Directives. Pyramid manufacturing always uses RoHS-compatible materials and processes.
Software Quality
At Pyramid, we take pride in developing software in alignment with IEC 62304 standards, ensuring the highest level of quality and safety for medical devices. Each software solution we create has its own specific compliance statement tailored to its unique requirements. While we do not offer formal IEC 62304 certification, we are committed to supporting our clients by providing comprehensive documentation needed for regulatory purposes, such as risk assessments or FDA 510(k) submissions. This enables our partners to meet their regulatory obligations with confidence and ease.