At CircleSpec, we prioritize health and safety by rigorously adhering to all FDA regulations and guidelines. Our products are developed and tested to meet the highest standards of quality and safety, ensuring compliance with FDA requirements at every stage of design and manufacturing. We are committed to delivering medical devices that not only meet but exceed regulatory expectations, safeguarding patient well-being and trust.

FDA Regulations (21 CFR Part 820): Ensures devices meet safety and effectiveness criteria in the U.S.
ISO 13485: An international standard for quality management systems specific to medical devices.
CE Marking (European Union): Indicates conformity with European health, safety, and environmental protection standards.
ISO 14971: Focuses on risk management for medical devices.
Good Manufacturing Practices (GMP): Ensures devices are consistently produced and controlled.