Good Manufacturing Practices Regulation Lawyers
What is the GMP Regulation?
The GMP applies to all domestic and foreign manufacturers of medical devices used in this country. It requires that these manufacturers must develop a quality assurance program so that the manufacturer can reduce the risk of any defective products making it out into the market for healthcare facilities or the general public to purchase.
What Are Some of the Requirements of this Quality Assurance Program?
For one thing, when designing the device, the manufacturer should have procedures that require that the user and patient be taken into consideration when the product is designed. In other words, the product must be reasonably easy for the operator to use. Sometimes the operator is the patient herself, and so the manufacturer should take this into account when designing the device. In addition, manufacturers should check the ease of use of their product by coming up with tests/surveys that gather information about the use of the device in the real world.
This can be done by simply having a group of people who would represent the potential operators in the real world, test out the device and then comment on its ease of use. Manufacturers must also assess the risk of using the device so that they are aware of the kinds of dangers it could pose to a potential operator or patient. After a basic design analysis, this can be assessed by the same method mentioned above in which the use of the device is tested by a qualified group of potential operators.
What Can I Do if I Have Experienced the Detrimental Effects of a Medical Device Malfunctioning and Suspect the Manufacturer Did Not Abide by the GMP Regulation?
You may want to contact a personal injury attorney who has had experience dealing with defective product cases. Your attorney can advise you of your rights and let you know if you may be entitled to compensation for any financial losses you incurred as a result of the defect (such as medical bills from an injury) in a lawsuit against the manufacturer.
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Last Modified: 07-23-2009 11:07 AM PDT