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Legal Compliance Needs of Medical Devices

Author: Sara Moly
by Sara Moly
Posted: Dec 28, 2015

Medical devices must follow the regulatory requirements of 21 CFR 820 to be considered within compliance. These strict guidelines assure adherence to federal regulations via audits.

There are compliance regulations that medical devices need to fall under for them to be approved for use. The regulations have to do with safety. The equipment can be safe, however diagnosis that is completed may be inaccurate and it is that diagnosis that is unsafe. The purpose of the regulation is to ensure that the diagnosis falls within compliance specified requirements. The diagnosis using medical technology evolves the complexity of medical equipment to such a high level that the diagnosis is more critical. Inaccurate diagnosis can be catastrophic. Regulations have been put in place to ensure the accuracy of medical equipment falls in compliance and that medical science does not fall behind because of the failures of medical equipment. Reliance on lifesaving medical science is based on the quality medical equipment.

Manufacturing of medical equipment is very detailed and very complex. The machinery to create the equipment needs to be precise and accurate. The components for medical equipment are complex because of their precision. This precision if not in balance can result in false diagnosis. A medical facility that uses equipment that inaccurately shows results causing a misdiagnosis can result in a malpractice lawsuit.

In today's legal environment in the medical profession, the ramifications to a facility or a doctor can be career ending. It is the responsibility of a medical facility using equipment that performs diagnosis to be accurate in every way. This means the equipment required by a medical facility falls under legal compliance. As part of that legal compliance, the equipment needs to be calibrated intestine routinely. If this is not done, then the equipment fails certification.

The manufacturer of any equipment used for a medical diagnosis is required to be inspected for quality and system compliance with the requirements of 21 CFR 820. Manufacturers who are under compliance 21 CFR 820 are recognized as expertise builders of medical devices. This recognition assures the medical community that the medical equipment is authorized for use for medical diagnosis. Any equipment that is not compliant under the requirements of 21 CFR 820, are subject to unannounced inspections and regulatory audits. A manufacturer that is found to have failed in the inspection or on it can be subject to fines and be prohibited from continued manufacturing. Manufacturers of medical devices must go through prior inspection that satisfies the requirements of 21 CFR 820, if they want to have a long term successful relationship with the medical community.

By sharing the requirements of 21 Cfr 820, manufacturer of medical equipment and devices is considered actively involved in keeping with standards and being part of proper standards development and implementation. This type of performance ensures the medical devices manufactured are at the top of their industry in a position of prestige and respect. They are considered to be authenticated and trusted. Medical facilities rely on manufacturers who are recognized to satisfy the requirements. 21 CFR 820 is considered a primary source of authorized equipment that is authenticated to meet specification that ensures accurate diagnosis. The manufacturers that support the development of this equipment have higher standards to follow. The standards to follow are the regulations associated with being compliant with 21 CFR 820.

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Author: Sara Moly

Sara Moly


Member since: Sep 25, 2015
Published articles: 12

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