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Medical Systems High Quality Medical Devices Articles & Analysis
6 articles found
Watertown, MA, July 22, 2024 – Biopharma PEG, a top supplier of PEG derivatives, is excited to introduce its new line of monodispersed PEGs. These specially sized polymers are designed to improve the stability and delivery of proteins and peptides in drugs. They are essential for Antibody-Drug Conjugate (ADC) linkers, Proteolysis Targeting Chimeras (PROTAC) linkers, and PEGylated proteins ...
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. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
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. According to a recent U.S. Food and Drug Administration (FDA) Medical Device Enforcement and Quality Report, the agency has increased annual inspections at manufacturing facilities ...
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