R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

RQS Feature Article - Successfully Addressing Warning Letters

Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA warning letters are not to be taken lightly, and the careful handling of them is critical to ensuring your business can move foward to produce safe and effective product. The article provides five great bullet-points of advice on putting your company on the right track with the FDA

Thoughts About Auditing

'Tis the season for auditing. The beginning of this year, just like years in the past, seems to have brought the New Year's Resolution that audits will be scheduled and conducted to correct the sins of the previous year and take a fresh look at the upcoming year. To this point I've conducted three audits and after this week I'll have been the auditee twice (essentially an audit per week to start the year).

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