Regulatory

At Medspira, product quality and customer satisfaction are a primary focus. All employees are aware and proud of their individual contributions to our effort to continually improve all levels of quality and customer satisfaction. Quality is considered in every stage, from development through distribution.

The Medspira quality management system enables us to organize, automate and document the design and manufacture of all products with the highest degree of compliance and efficiencies. Our quality management system is highlighted by our quality management system manual, standard operating procedures (SOPs), specific product procedures and records. We regularly update our procedures to ensure that we continuously improve our device commercialization process and maintain our regulatory compliance.

Medspira LLC is FDA registered and ISO 13485 certified. Our FDA registration number is 3008414621.

To view our regulatory certifications click on the links below.

FDA Approval Letter Biofeedback Device

FDA Approval Letter K120088 mcompass

FDA approval CT Bellows-IBC

FDA approval bc10 1.5 coil

FDA approval bc10 3.0 coil

CE Certification – mcompass

ISO13485

ISO13485 – Canada

CE Certification – BC-10 MRI Coil

Biofeedback Approval 252-858-03-Approval-Letter

Biofeedback Approval Ce-Cert-2018

Biofeedback Approval ISO13485