What is Fourslide forming, what are some advantages it offers to medical device component manufacturers, and why is it ideal for certain types of manufacturing? A discussion with experts from Acme Monaco .
What is Fourslide forming, what are some advantages it offers to medical device component manufacturers, and why is it ideal for certain types of manufacturing? A discussion with experts from Acme Monaco .
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.
Systems thinking is a disciplined way of thinking beyond the traditional boundaries of a product, and considers the complete flow of information or activities across a cooperating set of systems and human interventions to complete an intended job. For healthcare, this includes the span of activities for people, devices, information systems, and processes needed to meet various clinical and home healthcare scenarios.
Systems thinking is a disciplined way of thinking beyond the traditional boundaries of a product, and considers the complete flow of information or activities across a cooperating set of systems and human interventions to complete an intended job. For healthcare, this includes the span of activities for people, devices, information systems, and processes needed to meet various clinical and home healthcare scenarios.
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.
With a lot of focus on human factors in healthcare, and an increasing number companies developing devices destined for use outside the hospital, there’s particular interest in the challenges surrounding home healthcare.
With a lot of focus on human factors in healthcare, and an increasing number companies developing devices destined for use outside the hospital, there’s particular interest in the challenges surrounding home healthcare.
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.
We now test the possible causes against the facts in the IS / IS NOT Diagram to see which ones make sense. This is where the investments made in defining the problem and getting the facts pay off!
