Viewpoints
Writing Technical, Practical, and Theoretically interesting blogs
Major ISO 14971:2019 Changes That All Users and Manufacturers Should Know.
The latest version of ISO 14971:2019 has 8 major changes that all users and manufacturers should be aware of. Most of these following requirements have been called out in MDR: The 1st change focuses on the benefits expected from the use of the medical device and the use of benefit-risk analysis. By referring Technical, Regulatory, Economic, and Sociological context, the benefit-risk...
Aug 26, 2020
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A Strategy for Responding Appropriately to FDA.
There has been a tremendous increase in the number of FDA inspections that have occurred during the past few years. In addition, the level of scrutiny, during a typical inspection, has increased. Is your company ready to face an FDA Inspection? The FDA issues a Form 483 once they have completed the inspection of a medical device manufacturer’s facility. The FDA Form 483 is...
Nov 16, 2019
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Best Practices for Storing Data Intelligently for Faster CER Updates
I have performed more than two dozen new CERs and CER updates in the last 24 months. MEDEV 2.7/1 Rev 4 provides good guidelines on how to create and update a CER. At the same time, it does not clearly provide detailed pathway for the report structure and storing support data. In many cases, we found that once a clinical evaluation report is complete; there is no proper method to store supporting...
Nov 16, 2019
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Are You Paying Exorbitantly for Your Quality and Regulatory Consultants.
I was talking with my CEO one day and he expressed concern regarding the cost our company was incurring on Quality and Regulatory consultants and notified bodies. We are a small Orthopaedic firm which designs and distributes implant systems and instrument for Trauma applications. We need to follow and maintain compliance with all the regulations in the markets where we have sales. As I come from...
Jul 06, 2019
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