Although customer property and the management and handling of customer-supplied material is not important for FDA, that is clearly not the case for MHLW. And, preservation of products is important in all regulatory environments, so create a robust SOP with sufficient granularity to address all Article 52 requirements.
Much of the information gathered during evaluation in the early stages of product development is necessarily qualitative. Some quantifiable questions remain: how much deviation is there in the angle at which different doctors hold a laprascopic device? How does the movement of someone wearing a brace compare to that of a healthy person? Questions such as these can be answered using computer vision.
Identification and traceability are basic foundations associated with product realization, manufacturing, and ultimate distribution of finished medical devices. And the device world takes generally accepted identification and traceability requirements, and places them on steroids.
This week’s guidance is all about the manufacturing control of sterile medical devices, validation, and more validation.
As corporations look for diverse expertise and variable costs through outsourcing as well as looking to bring more through the pipeline with ever tighter resources, the challenges to managing the outsourced partners also increase.
For device manufactures failing to comply with Ministerial Ordinance 169, “gomen nasai” will be the first three words received from PMDA, followed by “your company’s medical devices are not approved for introduction into Japan’s device market place.”
There has been a sharp increase in regulatory oversight in the medical device industry. If your manufacturing requirements aren’t specific enough, your contract manufacturer might unknowingly make a problematic substitution. Which requirements are most important for your product? This week’s Ask the Engineer addresses material types, critical features and measurement methods.
There has been a sharp increase in regulatory oversight in the medical device industry. If your manufacturing requirements aren’t specific enough, your contract manufacturer might unknowingly make a problematic substitution. Which requirements are most important for your product? This week’s Ask the Engineer addresses material types, critical features and measurement methods.
Purchasing and supplier management is one area where a supplier’s poor performance can have a direct impact on the safety and efficacy of a finished medical device. In fact, a bad supplier can easily result in a product recall.
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.
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.
“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.
