Tag: medical device regulation consultant


Importance of Data Integrity and Document Management

In recent years there has been increased emphasis on data integrity, as this is a critical factor for the manufacturer in measuring the quality of their product and their credibility. What is Data integrity? Every organisation knows the saying, ‘If it isn’t written down, it didn’t happen’, this is fundamental in a manufacturing environment. Data is essential in the manufacturing process, without data how can the integrity of the product or processes be proven, without data it is harder to identify risks and opportunities for improvement. The FDA identify data integrity as......

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The CE Mark matters in medical markets

Selling any product into the European market can be simplified if a manufacturer can show that it complies with appropriate regulations. For medical device manufacturers, this compliance is vital.  Regulatory strategy planning is a critical step in the development and marketing of any medical device so it is important to understand the regulatory requirements of target markets, which can be quite different from country to country. It is equally important to have a clear understanding of the intended use, indications and claims for a device as these influence how to classify or......

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