A corrective action procedure requires a significant amount of intelligent thought to ensure all aspects required of an effective corrective action process are captured. Plan ahead and incorporate the preventive action requirements (Article 64) into the corrective action procedure; thus, creating a CAPA procedure.
Make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers get the complaint management piece right, let’s focus on what is often missed.
As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.
As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.
It is not enough for device manufacturers to simply clone a QMS or develop procedures employed for device manufacturing. Manufacturers must be able to gauge the effectiveness of their policies, procedures and processes, and provide objective evidence that their approach to quality and the manufacturing of devices is effective.
“Failing to properly plan is a plan for failure”—truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.
“Failing to properly plan is a plan for failure”—truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.
Chapter one of MO 169 establishes the foundation needed for manufacturers to gain entry into the Japanese market for their products. Complying with all of the requirements delineated throughout MO 169 is not only the expectation, it is mandated by law.
Chapter one of MO 169 establishes the foundation needed for manufacturers to gain entry into the Japanese market for their products. Complying with all of the requirements delineated throughout MO 169 is not only the expectation, it is mandated by law.
There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.
There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.
Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169.
During the course of the last eight months, Dr. D has had the opportunity to dive into 98/79/EC, the European In-Vitro Diagnostic Medical Device Directive while extracting salient elements in the hope of providing Devine Guidance for the readers. This journey has now come to an end.
Dr. D has just one takeaway from this edition of DG; “Just comply baby!” It does not get any easier than that, well maybe not that easy.
