Medical Device Compliance
Medical Device Compliance & Quality
Solutions
- Medical devices cover a wide range of health or medical instruments used in the treatment, mitigation, diagnosis, or prevention of a disease or abnormal health condition. These devices include syringes, thermometers, pacemakers, catheters, patient monitors, and others.
- In the United States, FDA (Food and Drug Administration) is responsible for regulating the safety and effectiveness of medical devices.
- Medical devices in the United States are classified into Class I, Class II, and Class III. The regulatory control increases from class I to class III with the increase in risk associated with medical devices.
- Most Class I devices are exempt from premarket notifications 510(K), most Class II devices require premarket notification 510(K) and most Class III devices require premarket approval.
Services Provided by CanSat Consulting
- Establishment Registration
- FURLS listing (Medical device listing)
- Premarket Notification 510(K)
- Premarket approval (PMA)
- Designing standard operating procedures
- Training programs for entry, mid-level, and senior management
- Site and QMS audit services (a must before regulatory inspections)
- Preparing and reviewing compliant labels