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Your approach seems valid. To it, I would add a suggestion to ensure that you look at the indications for use and ensure you have appropriate clinical evidence to demonstrate scientific validity, analytical performance and clinical performance.  TO your approach, I would also include a systematic review ...

Hello Tonia, There certainly is a range of costs depending upon the type of company and the location of said company. I'd love an opportunity to meet with you to discuss your needs and how we might be able to help you. We are a full-service consulting firm, partnering with our clients to provide ...

Hello Karen, With the increased clinical evidence expectations for EU MDR, it is wise to consider how your clinical evidence can be applied to other geographies. Most countries require some type of evidence of safety and performance/effectiveness for the device when used as intended in the correct ...

Hello! I plan to attend and look forward to meeting you.  Are there any specific questions you have about the EU regulatory system? Can you provide some general discussion of the differences between the Notified Bodies' expectations and practices? What is your level of knowledge/ experience with ...

I have a client working with a vendor to conduct welding testing, and the vendor is claiming that welding parameters are confidential and will be redacted within reports. In addition, they propose redacting specific details from the validation protocol and report, INCLUDING process parameters. They will ...