MedSpira
612-789-0013
1-800-345-4502

info@medspira.com

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 mcompass

FDA Approval Letter K120088 mcompass

FDA approval CT Bellows-IBC

CE Certification – mcompass

ISO13485

Biofeedback Approval 252-858-03-Approval-Letter

December 2018 Declaration of Conformity Combo RMD

Recent Posts

AUGS/IUGA Joint Scientific Meeting 2019

AUGS/IUGA Joint Scientific Meeting 2019 Come visit us at the American Urogynecologic Society (AUGS) and International Urogynecological Association (IUGA) , Booth #711 Music City Center, Nashville TN September 24th – 28th About AUGS/IUGA 2019 In 2019, the American...

Florida Gastroenterologic Society 2019

Florida Gastroenterologic Society 2019 Come visit us the Florida Gastroenterologic Society (FGS) Annual Meeting, Booth #300 Hilton Orlando Bonnet Creek Resort, Orlando FL September 13th – 15th, 2019 About FGS FGS strives to be the organization of choice for Florida...

American Society of Colon & Rectal Surgeons 2019

American Society of Colon & Rectal Surgeons 2019 Come visit us at the American Society of Colon & Rectal Surgeons  (ASCRS) Annual Scientific Meeting, Booth #727 Huntington Convention Center of Cleveland, Cleveland OH June 1st – 5th, 2019 About ASCRS With emphasis on...