Medical devices that are safe and effective are rooted in a robust design and it is impossible to design a medical device that is safe and effective, in its intended use, without the establishment of a well-documented design and development process.
“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.
There’s just one takeaway from this week: If your organization already has a QMS premised on EN ISO 13485:2003, then you probably already comply. However, if your organization has identified design and development or product realization as excluded or not applicable within the Quality Manual, then it becomes; “Captain I think we have a problem!”
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.
The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”
This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.
Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.