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.
Do not be that organization that gets stuck buying green catheter handles, when the requirement is for white. Article 61 does not tell device manufacturers what data needs to be collected and analyzed. It is completely up to each organization to decide. Remember, your organization, your data, so you decide what data is important.
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.
The control of nonconforming product should never be an onerous task. Keep it simple by never allowing non-conforming product to make its way into your organization’s supply chain. While UAI is convenient, eventually the use of such concessions is going to break your heart.
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.
Internal audits, regardless of the regulatory environment, are a fundamental requirement for an effective QMS. ISO 13485:2012; 21 CFR, Part 820, and MO 169, each clearly specifies that device manufacturers must plan and perform internal quality audits in order to gauge the overall effectiveness of the QMS.
When we understand that profitability is a vital part of the equation, it’s easy to see why Sustainability is a challenge worth embracing. By optimizing an existing design, or redesigning to minimize disposable elements, we can make a significant and positive difference.
This week’s guidance is rooted in two basic concepts: device manufactures should monitor and analyze the effectiveness of tools employed to demonstrate product and QMS conformity; and two, device manufacturers should actively seek feedback from their customers, including post-product performance of products.
Through Inclusive Design, people are given the opportunity to continue doing the things that provide them with quality of life. It’s also about using advanced technology without making things complicated and putting user needs first, without sacrificing profit or aesthetic advantages.
The bottom line in regards to compliance with Ministerial Ordinance 169 (MO 169) is quite simple: Equipment employed for the monitoring, measuring, testing, and/or inspection of medical devices must be properly maintained and calibrated. And this requirement applies to your suppliers as well.
