Biomimicry – Ideas From a Wasp’s Ovipositor
What can an ovipositor can do? How does it relate to space exploration and medical devices? Let’s explore what makes these Ichneumonoidea wasps so interesting.
MHLW MO 169 – Chapter 2/Section 4 – Resource Management
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.
MHLW MO 169 – Chapter Two/ Section 3 – Management Responsibility
In support of ensuring an effective QMS is sustained in accordance with MO 169, management responsibility should be considered a mission-critical requirement.
In support of ensuring an effective QMS is sustained in accordance with MO 169, management responsibility should be considered a mission-critical requirement.
MHLW MO 169 – Chapter Two – Quality Management System
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.
MHLW MO 169 – Chapter Two: General Rules
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’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!”
Sustainability in Medical Device Design – Packaging
As with other aspects of medical device design, medical packaging has its own unique set of challenges. Taking a big step back and reconsidering our assumptions can help us make the kind of impact necessary to ensure our future.
Reusable Medical Devices
Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.
Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.
MHLW MO 169 – Chapter One
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.
MHLW Ministerial Ordinance 169
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.
MEDdesign: Utilizing Data to Influence Tomorrow’s Design
Whether you are designing an autonomous surgical robot, a patient-specific knee implant, or a paperweight for all the new regulations, volumes of data are useless without the proper specification framework to filter and process it.
