…technical data should begin (but not end) by completing an Annex I – General Safety and Performance Requirements (GSPR) checklist. Completing the GSPR checklist will allow the manufacturer to see…
…technical data should begin (but not end) by completing an Annex I – General Safety and Performance Requirements (GSPR) checklist. Completing the GSPR checklist will allow the manufacturer to see…
…and legal requirements focus on the principle of single-fault safety, which means that a single first(-occurring) fault must not cause any hazards for either users or patients or result in…
…and legal requirements focus on the principle of single-fault safety, which means that a single first(-occurring) fault must not cause any hazards for either users or patients or result in…
Technology is not only an enabler of supply chain management but is fast disrupting trends and practices. Think IoT, industrial robotics, other embedded systems on the shop floor, data-driven inventory…
Technology is not only an enabler of supply chain management but is fast disrupting trends and practices. Think IoT, industrial robotics, other embedded systems on the shop floor, data-driven inventory…
…may receive a negative certification decision or require additional pre- and post- market clinical evidence under the MDR. The MDR has created much uncertainty amongst all of the stakeholders. Often,…
…may receive a negative certification decision or require additional pre- and post- market clinical evidence under the MDR. The MDR has created much uncertainty amongst all of the stakeholders. Often,…
Download this white paper today and find out how operational excellence for medical devices helps enterprises go beyond the complex modern requirements of medical device manufacturing. Learn how eliminating manual…
Download this white paper today and find out how operational excellence for medical devices helps enterprises go beyond the complex modern requirements of medical device manufacturing. Learn how eliminating manual…
…must get their products manufactured, complete the regulatory process and place their product on market faster than their competitors. The high-value role of MES is seen in basic work-in-process tracking…
…must get their products manufactured, complete the regulatory process and place their product on market faster than their competitors. The high-value role of MES is seen in basic work-in-process tracking…
…timeframe. Changes in the operation while fulfilling orders because of faulty quotes are a common thing customers struggle with. Also, the time to process quotes after the customer commits is…
…timeframe. Changes in the operation while fulfilling orders because of faulty quotes are a common thing customers struggle with. Also, the time to process quotes after the customer commits is…
Specifically designed for the Medical and Mobility industry’s complex and custom products, discover how CPQ (configure, price, quote) software can help your company save money, increase customer satisfaction, and generate…
Specifically designed for the Medical and Mobility industry’s complex and custom products, discover how CPQ (configure, price, quote) software can help your company save money, increase customer satisfaction, and generate…
What is a pre-assessment? Geoff Wood: A pre-assessment (PA) is a survey of a medical device manufacturer’s quality management system (QMS) held well in advance of a stage 1 and…
What is a pre-assessment? Geoff Wood: A pre-assessment (PA) is a survey of a medical device manufacturer’s quality management system (QMS) held well in advance of a stage 1 and…
