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

Contact Us

10 + 3 =

Recent Posts

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...

Digestive Disease Week 2019

Digestive Disease Week 2019 Come visit us at Digestive Disease Week (DDW), Booth #3321 San Diego Convention Center, San Diego CA, May 18th – 21st, 2019 About DDW Recognized as one of the top 50 medical meetings by HCEA, Digestive Disease Week® (DDW) is the world's...

New York Society for Gastrointestinal Endoscopy 2018

Come visit us at the upcoming New York Society for Gastrointestinal Endoscopy (NYSGE) Annual Course, Booth # 608. New York Marriott Marquis Hotel, New York NY December 13th – 14th, 2018. About NYSGE The New York Society for Gastrointestinal Endoscopy (NYSGE) was...