Tag Archives: medical device summit

Devine Guidance

What Part of Death or Serious Injury is Not Being Understood?

By Dr. Christopher Joseph Devine
No Comments

Being delinquent in your establishment’s medical device reporting responsibilities is going to elevate FDA’s concern and bring an appropriate response for offending device manufacturers, including a warning letter. This week’s guidance reviews the sins of an offending establishment and discusses some of the salient requirements associated with complying with 21 CFR, Part 803.

Being delinquent in your establishment’s medical device reporting responsibilities is going to elevate FDA’s concern and bring an appropriate response for offending device manufacturers, including a warning letter. This week’s guidance reviews the sins of an offending establishment and discusses some of the salient requirements associated with complying with 21 CFR, Part 803.

Continue reading

Devine Guidance

Lost in Translation

By Dr. Christopher Joseph Devine
No Comments

Many American-based devices companies are linguistically challenged when it comes to languages other than English, including UK version of English. However, letting your next door neighbor translate marketing material because Spanish is their native tongue is just insane.

Many American-based devices companies are linguistically challenged when it comes to languages other than English, including UK version of English. However, letting your next door neighbor translate marketing material because Spanish is their native tongue is just insane.

Continue reading

Devine Guidance

Try Obtaining Clearance First, Dudes

By Dr. Christopher Joseph Devine
No Comments

When in doubt about determining the correct device classification, it is always best to contact someone that actually has a thorough understanding of the regulations. In fact, you can even contact FDA.

When in doubt about determining the correct device classification, it is always best to contact someone that actually has a thorough understanding of the regulations. In fact, you can even contact FDA.

Continue reading