Time for Reflection
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.
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.
Swift, frequent prototyping and testing, combined with tightly-integrated design and engineering, can help guide your project from opportunity identification, through market release.
How heat-resistant are light-curing adhesives, and can these adhesives be over-cured and break down? This week’s Ask the Engineer answers these and more.
How heat-resistant are light-curing adhesives, and can these adhesives be over-cured and break down? This week’s Ask the Engineer answers these and more.
UDI is finally upon us, so embrace the change and begin working toward compliance.
While a systems engineering approach will not, in and of itself, resolve all challenges currently faced by the medical device industry, it is the cornerstone and framework for allowing organizations to begin addressing these challenges by adopting a more holistic, efficient and systematic approach to product realization.
While a systems engineering approach will not, in and of itself, resolve all challenges currently faced by the medical device industry, it is the cornerstone and framework for allowing organizations to begin addressing these challenges by adopting a more holistic, efficient and systematic approach to product realization.
Most of you are aware of the lack of exceptions in regards to quality and regulatory compliance. However, FDA has graciously given special dispensation to medical device establishments when it comes to three types of records – management reviews; internal audits; and supplier audits.
When implementing a Part 11 compliance program, it is all about three important words: validation; validation; and validation.
Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit a device manufacture, resulting in Dr. D’s favorite six-letter word – RECALL.
There are many manufacturing pitfalls associated with physical architecture, vendor selection, and details like specifying the correct coating on a part – that come with the territory. Address these five themes to avoid problems and achieve your manufacturing goals.
There are many manufacturing pitfalls associated with physical architecture, vendor selection, and details like specifying the correct coating on a part – that come with the territory. Address these five themes to avoid problems and achieve your manufacturing goals.
Material management is one of the most basic functions needed to successful manufacture finished medical devices. If adequate controls are not maintained over raw materials and appropriate identification and traceability maintained, then there will probably be a FDA Form 483 observation in your organization’s future.