…requirements that may eventually affect their ability to sell products. In this issue of Ask the Expert, UL experts respond to questions about both existing and future requirements. Q: What…
…requirements that may eventually affect their ability to sell products. In this issue of Ask the Expert, UL experts respond to questions about both existing and future requirements. Q: What…
…make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process. Q: “My team is under…
…make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process. Q: “My team is under…
…difficult is it to meet this requirement? Ask a caveman, he might know. Seriously folks; holding a management review meeting is simply a basic management task. A task that Dr….
…difficult is it to meet this requirement? Ask a caveman, he might know. Seriously folks; holding a management review meeting is simply a basic management task. A task that Dr….
…help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for home use devices and sterilization techniques. Q: “I am developing a medical device…
…help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for home use devices and sterilization techniques. Q: “I am developing a medical device…
With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems….
With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems….
…particular formulation of silicone tubing, more than one sterilization method can be accommodated. Ask your supplier(s) which types of sterilization their silicone tubing can handle. Learn more Q: How do…
…particular formulation of silicone tubing, more than one sterilization method can be accommodated. Ask your supplier(s) which types of sterilization their silicone tubing can handle. Learn more Q: How do…
…companies to drive operational efficiency and revisit material selection in order to succeed in the future global medical marketplace. This week, Ask the Expert focuses on material selection that opt……
…companies to drive operational efficiency and revisit material selection in order to succeed in the future global medical marketplace. This week, Ask the Expert focuses on material selection that opt……
…Trautman (FDA QSR Expert) expanded on the increasing number of recalls driven by poor supplier performance. Additionally, the SCAR becomes an important metric when measuring the overall performance of your…
…Trautman (FDA QSR Expert) expanded on the increasing number of recalls driven by poor supplier performance. Additionally, the SCAR becomes an important metric when measuring the overall performance of your…
…Trautman, the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices and Quality System Regulations expert, suppliers providing non-conforming materials are directly related to an increase in medical device…
…Trautman, the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices and Quality System Regulations expert, suppliers providing non-conforming materials are directly related to an increase in medical device…
…just not viable options today. In the coming months, I would like to enlist my colleagues and ask that you read my ranting, even if these views and concepts appear…
…just not viable options today. In the coming months, I would like to enlist my colleagues and ask that you read my ranting, even if these views and concepts appear…
