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

ISO13485 – Canada

Biofeedback Approval 252-858-03-Approval-Letter

Contact Us

13 + 14 =

Recent Posts

Texas Society of Gastroenterology and Endoscopy 2018

Come visit us at the Texas Society of Gastroenterology and Endoscopy (TSGE) Annual Meeting, Booth #48 Austin Hilton, Austin TX September 21st – 23rd, 2018 About TSGE Texas Society for Gastroenterology and Endoscopy is a statewide professional association for...

Florida Gastroenterologic Society 2018

Come visit us the Florida Gastroenterologic Society (FGS) Annual Meeting, Booth #324 Hyatt Regency Grand Cypress, Orlando FL September 14th – 16th, 2018 About FGS FGS strives to be the organization of choice for Florida Gastroenterologist. We work for members in...

American Urogynecologic Society 2018

Come visit us at the American Urogynecologic Society (AUGS) PFD Week, Booth #308 Hyatt Regency Chicago, Chicago IL October 9th – 13th About AUGS PFD Week 2018 PFD Week was created by AUGS to become the go-to meeting for health care professionals interested in or...