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points to consider.
RISK MANAGEMENT IN MEDICAL DEVICE DESIGN The key to successful risk management in medical device design is to start early. As soon as conceptual designs are available, the risk management process can begin. A preliminary hazard analysis can be useful in selecting the concept with the highest level of inherentsafety.
GET READY FOR THE HOSPITAL OF THE FUTURE DETERMINING SAMPLE SIZE FOR TESTING An MD&DI May 1997 Column HELP DESK Director, corporate statistical resources, at Medtronic, Inc. (Minneapolis), explains the statistical strategies used during clinical trials for determining equivalence and offers ways to calculate sample sizes. TOP 10 MOLECULAR DIAGNOSTICS COMPANIES: A CLOSER LOOK The list was compiled by analysis firm Kalorama Information. The names on the list are not surprising, but it's worth looking at them, and the molecular diagnostics industry in general, a little more closely to help determine what kind of factors translate to success in this exciting field. In 2012 MEDICAL DESIGN & MANUFACTURING (MD&M) EAST 2021 Medical Design & Manufacturing (MD&M) East 2021. Dec 07, 2021 to Dec 09, 2021. Jacob K. Javits Convention Center, New York City. See medtech innovation on display in New York City. Medtech moves fast. Keep the pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders. 2021 MEDICAL DESIGN EXCELLENCE AWARDS FINALISTS The Medical Design Excellence Awards competition is the medical technology industry's premier awards program. Since 1998, the MDEAs have recognized achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Each year, a panel of jurors REMOTE MEDICAL DEVICE SERVICING IS THE FUTURE Remote Medical Device Servicing Is the Future. Image courtesy of Dedicated Computing. Remote strategies add value even if the OEM does need to go out and do a physical repair. Remote diagnosis ensure the field tech arrives with the correct part in hand – no multi-step process or multiple visits are necessary. ROOT CAUSE ANALYSIS: ADVENTURES IN MEDICAL DEVICE Identifying the causes is the key to eliminating the errors. This is what Root Cause Analysis is all about--finding the causes of errors made in usability testing. The term "root cause" is used to emphasize that the goal is to find the "deep" or "underlying" causes, as opposed to the superficial causes. The root causes lead to things that can WHAT TYPES OF BIOCOMPATIBILITY TESTING DO YOU NEED TO On Thursday, December 4 at BIOMEDevice San Jose, Thor Rollins, in vivo biocompatibility section leader at Nelson Laboratories Inc. (Salt Lake City, UT), will speak on "Materials Selection and Sampling Techniques for Biocompatibility (ISO 10993)." Some of the themes that he will present at the conference are addressed in the following Q&A. MPMN: Please go into ISO 10993-1 and why 7 CONSIDERATIONS FOR CHOOSING A TESTING PARTNER Expectations for medical device testing are changing, thanks to evolving regulations and standards as well as other factors. Finding the right testing partner is critical for success, so here are a fewpoints to consider.
RISK MANAGEMENT IN MEDICAL DEVICE DESIGN The key to successful risk management in medical device design is to start early. As soon as conceptual designs are available, the risk management process can begin. A preliminary hazard analysis can be useful in selecting the concept with the highest level of inherentsafety.
GET READY FOR THE HOSPITAL OF THE FUTURE DETERMINING SAMPLE SIZE FOR TESTING An MD&DI May 1997 Column HELP DESK Director, corporate statistical resources, at Medtronic, Inc. (Minneapolis), explains the statistical strategies used during clinical trials for determining equivalence and offers ways to calculate sample sizes. TOP 10 MOLECULAR DIAGNOSTICS COMPANIES: A CLOSER LOOK The list was compiled by analysis firm Kalorama Information. The names on the list are not surprising, but it's worth looking at them, and the molecular diagnostics industry in general, a little more closely to help determine what kind of factors translate to success in this exciting field. In 2012 MEDICAL DEVICE SUPPLY-CHAIN OPERATIONS AND PANDEMIC The COVID-19 pandemic tested the resilience of supply chains. The medical device industry was no exception. The pandemic has disrupted everything from supply and demand to shipping and workplace capacity. Medical device companies have experienced delays within theirfacilities, and
ABBOTT SEES COVID-19 TESTING DEMAND DROOP AS RESTRICTIONS Abbott's outlook for rapid COVID-19 testing has changed significantly as the company has seen a sudden drop in COVID-19 testing demand due to shifting in guidelines related to testing for people who are fully vaccinated. In April, the company reported READY FOR A TURNKEY AUTOMATION TRANSFORMATION It’s not a new trend. But automation today is poised to reach new heights in medical device manufacturing. With skilled labor scarce and demand surging for products related to COVID-19, many companies are looking to incorporate automation to accelerate WHAT DOES TELEHEALTH’S POST-PANDEMIC FUTURE LOOK LIKE Before the global health crisis, seeking a consultation too often meant going in-person to a hospital or doctor’s office and waiting for a one-to-one appointment. The effectiveness, efficiency, and cost associated with telehealth were regarded with skepticism by providersand patients alike
REMOTE MEDICAL DEVICE SERVICING IS THE FUTURE Remote Medical Device Servicing Is the Future. Image courtesy of Dedicated Computing. Remote strategies add value even if the OEM does need to go out and do a physical repair. Remote diagnosis ensure the field tech arrives with the correct part in hand – no multi-step process or multiple visits are necessary. THE MEDICAL DEVICE INDUSTRY NEEDS RISK MANAGEMENT IN THE Amid the current COVID-19 pandemic, many medical device manufacturers and suppliers are moving at unprecedented speeds to develop and enact updated risk management policies and procedures. Much of what they are developing are plans to help manage manufacturing and supply-chain challenges in times of ABIOMED STRENGTHENS HF OFFERINGS WITH PRECARDIA Abiomed is augmenting its heart failure treatment offerings with the acquisition of preCARDIA for an undisclosed sum. St. Paul, MN-based preCARDIA has developed a catheter-based system designed to rapidly treat ADHF-related volume overload by reducing cardiac filling pressures and promoting decongestion to improve overall cardiac andrenal function.
ALIVECOR MOVES TOWARD AMBULATORY MONITORING SYSTEMS WITH AliveCor, an ECG technology specialist, is going in a bold direction with its newest acquisition. The Mountain View, CA-based company is purchasing CardioLabs, a monitoring and cardiac diagnostic service provider. AliveCor said the acquisition would set THE NEW AND IMPROVED ISO 10993-12:2021 Every time there is an update to a standard, especially an overarching one like the ISO 10993-12 standard that covers sample preparation recommendations, it comes with a slight dose of anxiety. This is because it might mean there is now a gap between what is VERILY STRIKES OUT ON ADDING PARKINSON’S ASSESSMENT TO 1 day ago · Verily Life Sciences has hit a snag in bringing a Parkinson’s disease exam tool to its research smartwatch. The Alphabet Company’s bid to add the virtual motor exam (VME III) was recently rejected by FDA. Data gathered as a result of the assessment could be used in drug development studies MEDICAL DESIGN & MANUFACTURING (MD&M) EAST 2021 Medical Design & Manufacturing (MD&M) East 2021. Dec 07, 2021 to Dec 09, 2021. Jacob K. Javits Convention Center, New York City. See medtech innovation on display in New York City. Medtech moves fast. Keep the pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders. 2021 MEDICAL DESIGN EXCELLENCE AWARDS FINALISTS The Medical Design Excellence Awards competition is the medical technology industry's premier awards program. Since 1998, the MDEAs have recognized achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Each year, a panel of jurors REMOTE MEDICAL DEVICE SERVICING IS THE FUTURE Remote Medical Device Servicing Is the Future. Image courtesy of Dedicated Computing. Remote strategies add value even if the OEM does need to go out and do a physical repair. Remote diagnosis ensure the field tech arrives with the correct part in hand – no multi-step process or multiple visits are necessary. ROOT CAUSE ANALYSIS: ADVENTURES IN MEDICAL DEVICE Identifying the causes is the key to eliminating the errors. This is what Root Cause Analysis is all about--finding the causes of errors made in usability testing. The term "root cause" is used to emphasize that the goal is to find the "deep" or "underlying" causes, as opposed to the superficial causes. The root causes lead to things that can WHAT TYPES OF BIOCOMPATIBILITY TESTING DO YOU NEED TO On Thursday, December 4 at BIOMEDevice San Jose, Thor Rollins, in vivo biocompatibility section leader at Nelson Laboratories Inc. (Salt Lake City, UT), will speak on "Materials Selection and Sampling Techniques for Biocompatibility (ISO 10993)." Some of the themes that he will present at the conference are addressed in the following Q&A. MPMN: Please go into ISO 10993-1 and why 7 CONSIDERATIONS FOR CHOOSING A TESTING PARTNER Expectations for medical device testing are changing, thanks to evolving regulations and standards as well as other factors. Finding the right testing partner is critical for success, so here are a fewpoints to consider.
RISK MANAGEMENT IN MEDICAL DEVICE DESIGN The key to successful risk management in medical device design is to start early. As soon as conceptual designs are available, the risk management process can begin. A preliminary hazard analysis can be useful in selecting the concept with the highest level of inherentsafety.
GET READY FOR THE HOSPITAL OF THE FUTURE DETERMINING SAMPLE SIZE FOR TESTING An MD&DI May 1997 Column HELP DESK Director, corporate statistical resources, at Medtronic, Inc. (Minneapolis), explains the statistical strategies used during clinical trials for determining equivalence and offers ways to calculate sample sizes. TOP 10 MOLECULAR DIAGNOSTICS COMPANIES: A CLOSER LOOK The list was compiled by analysis firm Kalorama Information. The names on the list are not surprising, but it's worth looking at them, and the molecular diagnostics industry in general, a little more closely to help determine what kind of factors translate to success in this exciting field. In 2012 MEDICAL DESIGN & MANUFACTURING (MD&M) EAST 2021 Medical Design & Manufacturing (MD&M) East 2021. Dec 07, 2021 to Dec 09, 2021. Jacob K. Javits Convention Center, New York City. See medtech innovation on display in New York City. Medtech moves fast. Keep the pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders. 2021 MEDICAL DESIGN EXCELLENCE AWARDS FINALISTS The Medical Design Excellence Awards competition is the medical technology industry's premier awards program. Since 1998, the MDEAs have recognized achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Each year, a panel of jurors REMOTE MEDICAL DEVICE SERVICING IS THE FUTURE Remote Medical Device Servicing Is the Future. Image courtesy of Dedicated Computing. Remote strategies add value even if the OEM does need to go out and do a physical repair. Remote diagnosis ensure the field tech arrives with the correct part in hand – no multi-step process or multiple visits are necessary. ROOT CAUSE ANALYSIS: ADVENTURES IN MEDICAL DEVICE Identifying the causes is the key to eliminating the errors. This is what Root Cause Analysis is all about--finding the causes of errors made in usability testing. The term "root cause" is used to emphasize that the goal is to find the "deep" or "underlying" causes, as opposed to the superficial causes. The root causes lead to things that can WHAT TYPES OF BIOCOMPATIBILITY TESTING DO YOU NEED TO On Thursday, December 4 at BIOMEDevice San Jose, Thor Rollins, in vivo biocompatibility section leader at Nelson Laboratories Inc. (Salt Lake City, UT), will speak on "Materials Selection and Sampling Techniques for Biocompatibility (ISO 10993)." Some of the themes that he will present at the conference are addressed in the following Q&A. MPMN: Please go into ISO 10993-1 and why 7 CONSIDERATIONS FOR CHOOSING A TESTING PARTNER Expectations for medical device testing are changing, thanks to evolving regulations and standards as well as other factors. Finding the right testing partner is critical for success, so here are a fewpoints to consider.
RISK MANAGEMENT IN MEDICAL DEVICE DESIGN The key to successful risk management in medical device design is to start early. As soon as conceptual designs are available, the risk management process can begin. A preliminary hazard analysis can be useful in selecting the concept with the highest level of inherentsafety.
GET READY FOR THE HOSPITAL OF THE FUTURE DETERMINING SAMPLE SIZE FOR TESTING An MD&DI May 1997 Column HELP DESK Director, corporate statistical resources, at Medtronic, Inc. (Minneapolis), explains the statistical strategies used during clinical trials for determining equivalence and offers ways to calculate sample sizes. TOP 10 MOLECULAR DIAGNOSTICS COMPANIES: A CLOSER LOOK The list was compiled by analysis firm Kalorama Information. The names on the list are not surprising, but it's worth looking at them, and the molecular diagnostics industry in general, a little more closely to help determine what kind of factors translate to success in this exciting field. In 2012 MEDICAL DEVICE SUPPLY-CHAIN OPERATIONS AND PANDEMIC The COVID-19 pandemic tested the resilience of supply chains. The medical device industry was no exception. The pandemic has disrupted everything from supply and demand to shipping and workplace capacity. Medical device companies have experienced delays within theirfacilities, and
ABBOTT SEES COVID-19 TESTING DEMAND DROOP AS RESTRICTIONS 1 day ago · Abbott's outlook for rapid COVID-19 testing has changed significantly as the company has seen a sudden drop in COVID-19 testing demand due to shifting in guidelines related to testing for people who are fully vaccinated. In April, the company reported READY FOR A TURNKEY AUTOMATION TRANSFORMATION 1 day ago · It’s not a new trend. But automation today is poised to reach new heights in medical device manufacturing. With skilled labor scarce and demand surging for products related to COVID-19, many companies are looking to incorporate automation to accelerate WHAT DOES TELEHEALTH’S POST-PANDEMIC FUTURE LOOK LIKE Before the global health crisis, seeking a consultation too often meant going in-person to a hospital or doctor’s office and waiting for a one-to-one appointment. The effectiveness, efficiency, and cost associated with telehealth were regarded with skepticism by providersand patients alike
REMOTE MEDICAL DEVICE SERVICING IS THE FUTURE Remote Medical Device Servicing Is the Future. Image courtesy of Dedicated Computing. Remote strategies add value even if the OEM does need to go out and do a physical repair. Remote diagnosis ensure the field tech arrives with the correct part in hand – no multi-step process or multiple visits are necessary. THE MEDICAL DEVICE INDUSTRY NEEDS RISK MANAGEMENT IN THE Amid the current COVID-19 pandemic, many medical device manufacturers and suppliers are moving at unprecedented speeds to develop and enact updated risk management policies and procedures. Much of what they are developing are plans to help manage manufacturing and supply-chain challenges in times of ABIOMED STRENGTHENS HF OFFERINGS WITH PRECARDIA Abiomed is augmenting its heart failure treatment offerings with the acquisition of preCARDIA for an undisclosed sum. St. Paul, MN-based preCARDIA has developed a catheter-based system designed to rapidly treat ADHF-related volume overload by reducing cardiac filling pressures and promoting decongestion to improve overall cardiac andrenal function.
ALIVECOR MOVES TOWARD AMBULATORY MONITORING SYSTEMS WITH AliveCor, an ECG technology specialist, is going in a bold direction with its newest acquisition. The Mountain View, CA-based company is purchasing CardioLabs, a monitoring and cardiac diagnostic service provider. AliveCor said the acquisition would set THE NEW AND IMPROVED ISO 10993-12:2021 Every time there is an update to a standard, especially an overarching one like the ISO 10993-12 standard that covers sample preparation recommendations, it comes with a slight dose of anxiety. This is because it might mean there is now a gap between what is VERILY STRIKES OUT ON ADDING PARKINSON’S ASSESSMENT TO 14 hours ago · Verily Life Sciences has hit a snag in bringing a Parkinson’s disease exam tool to its research smartwatch. The Alphabet Company’s bid to add the virtual motor exam (VME III) was recently rejected by FDA. Data gathered as a result of the assessment could be used in drug development studies We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy . By continuing to use the website, you consent to our use of cookies.×
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