Developing a Risk Management Strategy for Medical Devices in the US Market
Risk management is an essential component of regulatory compliance for medical device companies marketing their products within the US. Yet, since risk management requirements have evolved over the course of more than a decade, it is not possible for a regulatory professional to rely upon just one source to determine exactly what type of risk management system should be implemented to comply with US regulations.
Spring 2010 Newsletter
Flip the Switch
Root cause analysis can shine the spotlight on the origin of a problem. By Gary G. Jing
Have you found the root cause yet??
We frequently ask or hear others ask that question. Root cause analysis (RCA) is an old subject and is familiar to many people. You might assume quality professionals would have a clear understanding of this technique.
Summer 2008 Newsletter Process Validation Prerequisites 101
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the accumulation of documented evidence that demonstrates with a high degree of assurance that a process can consistently meet its predetermined specifications and quality attributes.
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Spring 2008 Newsletter Revised EU Directives
Since the European single market activities of the late 1980s, three main medical device directives have passed into law in the countries that make up the European Union (EU). These New Approach directives regulate how devices may be placed on the market and identify postmarketing vigilance requirements. Download Newsletter
Fall 2007 Newsletter How to Manage an FDA Inspection
For everyone involved, FDA inspections are time-consuming and labor-intensive processes, but they needn?t be frustrating or mysterious if a company has prepared properly. The most important preparation is complying with the pertinent laws and regulations, including developing safe and effective products and implementing an effective quality system.
Summer 2007 Newsletter Auditing a Device Company-It's just paperwork?
When FDA inspects a device facility, it is natural for the staff to be concerned and more than apprehensive. This is to be expected when the outcome can result in loss of stock value, income or personal advancement. However, when an auditor arrives, the reaction is the same.
GMP Labeling periodically publishes articles by quality professionals that we feel are useful and informative.
We hope that you find these articles helpful as a part of your continuing professional education.
Many FDA regulated businesses and ISO 9000 registered companies use GMP Labeling products to help them maintain compliance. More than 5,000 facilities in the USA, Canada and Europe use GMP Labeling products on a daily basis.
Developing a Risk Management Strategy for Medical Devices in the US Market
Flip the Switch
Summer 2008 Newsletter
Spring 2008 Newsletter
Fall 2007 Newsletter
Summer 2007 Newsletter
