Outsourcing manufacturing operations has been accepted as routine part of the product life-cycle process as device manufacturers are constantly weighing their options: build in-house versus outsourcing. What are some fundamental questions that need to be asked?
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.
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.
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.
It is acceptable to outsource just about every conceivable activity associated with medical device manufacturing. However, organizations can never outsource their quality and regulatory responsibilities, as failure to recognize and assume ownership and the wrath of our friends from the agency will be swift and painful.
The moral of this week’s guidance is: “Always do the right things!” However, for those of you with a moral compass that may not always point north, the moral of the story is; “Do not get caught!”
There is no such thing as minimum compliance or maximum compliance, there is just compliance.
To get Devine Guidance off with a bang in 2014, the doctor will begin by broaching a subject that continues to stymie many device establishments around the globe: supplier management and specifically, supplier audits.
For this week’s guidance, we reflect upon the medical device industry and the ongoing changes to the quality and regulatory environment and the industry as a whole.
UDI is finally upon us, so embrace the change and begin working toward compliance.
