quality-management

In the medical devices industry, “ design transfer ” refers to the process of transitioning a medical device from development to large-scale manufacturing. For manufacturers, particularly personnel in the quality, R&D, and manufacturing functions, a working knowledge of design transfer and compliance with requirements is essential. In this post, we’ll explain why design transfer is important, how…

In my experience as a quality professional, I have found that a CAPA medical device system is the most revealing part of a company's internal structure. I once worked with a team that had nearly 40 open files, some dating back eighteen months, because they treated the process as a secondary administrative task rather than a priority.

Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulatory consequences. For this reason, GMP certification is an essential prerequisite to be in the life science industry. If you are working on building a…

In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers. In this article, we will tell you the ins and outs of QMS implementation for medical devices. It’s truly the backbone of long-term success and innovation. For executives, quality managers, and compliance of…

This recertification provides assurance that NY CREATES’ quality management system consistently provides products and services which meet the stringent requirements of the internationally recognized ISO 9001 standard. The post NY CREATES’ Albany NanoTech Complex Receives Recertification from TÜV SÜD AMERICA INC. appeared first on Semiconductor Digest .