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Medical Device Quality Articles & Analysis
12 articles found
Quality issues in medical devices often point to underlying weaknesses in the system, and ISO 13485-compliant CAPA is essential for correctly identifying cause and preventing the problem from recurring. Here’s an overview of CAPA requirements in ISO 13485 for medical device ...
By sourcing from us, medical device manufacturers can ensure superior quality and reliability, making Edgetech Industries a valued partner in the industry. ...
Each step is pivotal in assuring that when scaled, the production of medical devices remains consistent, high in quality, and compliant with industry regulations. ...
Medical device biocompatibility testing is a quality control standard for the development and manufacturing of medical devices. ...
Media Contact: Biopharma PEG 108 Water Street, Suite 4D, Watertown, MA 02472, USA TEL: 1-857-928-2050 / 1-857-366-6766 sales@biochempeg.com About Biopharma PEG: Biopharma PEG is a leading supplier of PEG derivatives, dedicated to supporting the pharmaceutical, biotechnology, and medical device industries with high-quality products that enhance ...
Precision is not just a preference but a stringent requirement in medical equipment manufacturing. At the heart of this precision lies the role of medical-grade welding gas mixers, an important component in ensuring high-accuracy welding applications, particularly in environments where consistency and quality cannot be compromised. This blog post defines medical-grade welding gas mixers and ...
The use of tumour markers to diagnose, assess prognosis, and select a suitable cancer treatment has become possible due to the development of inexpensive and user-friendly molecular analysis tools such as the polymerase chain reaction (PCR). Maintaining the integrity of biomarkers during their processing and storage is therefore of critical importance to accurately diagnose and give prognosis ...
From conception to finished commercial product, medical devices requires innovative engineers and product designers, experienced project managers, quality control experts, and substantial regulatory expertise to make that transition a successful one. ...
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. ...
The processes and the technology have moved beyond anything that can be controlled via a paper-based system; you need an automated quality management system. How an automated Quality Management System gives medical device companies a competitive advantage The winners in the medical device ...
ByEtQ, LLC
The medical device industry is worth hundreds of billions of dollars, but companies who take their eye off the ongoing need for quality management could find themselves under an unwelcome federal compliance spotlight. ...
ByEtQ, LLC
What can medical device manufacturers learn from these tech giants? Let’s look at 4 of the most important lessons companies can use to improve quality and move confidently into the next era of innovation. ...
ByEtQ, LLC