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.
Tag Archives: medical devices
UDI – It’s About Time
UDI is finally upon us, so embrace the change and begin working toward compliance.
The QSR Exceptions to the Rules
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.
Part 11 Compliance – Don’t Forget to Validate
When implementing a Part 11 compliance program, it is all about three important words: validation; validation; and validation.
Ship the Finished Device to Where?
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.
5 Things You Should Know About Making a Medical Device Manufacturable
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.
Managing the Stockroom is not Rocket Science
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.
MDSAP is Coming Soon – What Do You Need to Know?
The underlying purpose of the Medical Device Single Audit Program is to allow one of five regulatory bodies to perform an inspection and then share the results with the other agencies so additional/duplicate inspections are not required.
Can You Say Calibration is a Basic Requirement?
What is required of an FDA compliant calibration program? How about crafting a program that actually results in inspection, measuring and test equipment actually being calibrated?
Environmental Conditions – Keep Records!
If a medical device establishment is manufacturing sterile medical devices, make sure that environmental monitoring and the calibration and servicing of environmental control systems are part of the product realization equation.
