Quality Assurance and Regulatory Compliance

Quality Assurance & Regulatory Compliance

Quality Assurance and Regulatory Compliance

Xodus Medical is an ISO 13485:2016 Certified Medical Device Manufacturer that focuses on increasing patient and healthcare-worker safety. We provide solutions that help our customers meet the requirements of The Joint Commission, CMS Never Events, OSHA, etc.

Our unwavering commitment to quality allows for consistent development and delivery of solutions that Make Surgery Safer, as well as maximize both customer value and satisfaction.

Registrations and Certifications

Xodus Medical maintains certifications for, and is governed by, the following United States and International regulatory bodies and standards:

FDA Registered as a medical device facility

Title 21 CFR Part 820

Establishment Registration

CFG Export Certificate

Audited for compliance by:

US FDA
Philadelphia District
Pittsburgh Resident Post
7 Parkway Center, Room 250
Pittsburgh, PA 15220

CE Mark certified for international sale of products

Medical Device Directive 93/42/EEC (MDD)
Medical Device Regulation (MDR)

Annev V

Annev Vs

Audited for compliance by:

GMED
1 rue Gaston Boissier
75724 Paris Cedex 15

ISO 13485:2016 certified

Voluntary certification establishes highest quality global standard

Certificate

Audited for compliance by:

GMED
1 rue Gaston Boissier
75724 Paris Cedex 15

Authorized European Representative

Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
Telephone: +31 70 345 8570
Emergo Website

Authorized Switzerland Representative

MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
Telephone: +41 41 562 01 42
MedEnvoy Website

Xodus Medical Exports to the Following Countries

Australia, Austria, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, South Korea, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, among others

Instructions for Use

A complete Instructions for Use (IFU) Library for Xodus Medical solutions is available here.

Help ensure patient and hospital-staff safety by closely reviewing applicable IFUs prior to using Xodus Medical products.

View the Symbol Glossary for explanation of symbols used on our IFUs and product packaging.

Material Safety Data Sheets

Supplied upon request

Manufacturer Warnings

Reuse of single use devices is prohibited due to the risk of cross contamination and/or infection.

Manufacturer Warnings

Reuse of single use devices is prohibited due to the risk of cross contamination and/or infection.