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Memo to EU Member States: Don’t Derail UDI
WELL, THAT WAS FAST. At its March 2013 meeting in Nice, France, the International Medical Device Regulators Forum (IMDRF) announced that it would release guidance on a unique device identification (UDI) system for public consultation in the “near future.” That is usually code for, &ldq...
(May, 2013)
Securing Inside Intelligence Using X-ray Inspection Systems
The increasing complexity of medical devices is driving advances in industrial x-ray technology.
(May, 2013)
Inside the A&D Medical NFC-Enabled Blood Pressure Monitor
Connectivity relies on near field communication technology, which is rarely used in medical applications.
(May, 2013)
US FDA Publishes Proposed Rule on Non-US Clinical Studies
If the proposed rule on US FDA requirements for accepting data from medical device clinical studies conducted outside the United States becomes final, manufacturers will face significant new requirements.
(May, 2013)
Sidebar: The Tenets of Value-Based Selling
Companies that articulate the overall value of a medical product or service have significantly higher customer retention, market share, revenues and profits, according to an Aberdeen Group study of 67 medical device, equipment and diagnostics industry executives. Global consulting firm ZS Associates...
(May, 2013)
Coloplast, Novo Nordisk and 3M among Finalists for MDEA Awards
MD+DI has announced the finalists of the Medical Design Excellence Awards (MDEA), a program honouring the best medical product manufacturers and suppliers, as well as the people behind the scenes. The award ceremony is celebrating its 15th anniversary on 19 June 2013, when the winners will be anno...
(April, 2013)
Sidebar: Extreme Makeover for Medtech Engineers
Go ahead, turn the world on its head. But you're not going to do it alone. After all, Steven Jobs did not invent the iPhone. He preached a vision that drove the Apple team to spectacular success. High-impact engineering for medical devices follows the same model, so get with a team, and lead that t...
(April, 2013)
New US Regulation on CGMPs for Combination Products
US FDA has recently published its long-awaited regulation on current good manufacturing practices (CGMPs) applicable to combination products. The regulation becomes effective on 22 July 2013 and applies to combination products already on the market in addition to newly developed products.
(April, 2013)
Rebuilding the Medtech Engineer
The balance is swinging from high tech to the human touch for medical technology companies, as the emphasis in product development shifts from functionality to regulatory compliance, cost-effectiveness and usability.
(April, 2013)
Pathways to Value-Based Selling and Market Success
Shifting demographics and a challenging economic environment are having a profound impact on the business dynamics of the medical device market in Europe. It’s time to get creative. Four EU companies show how.  
(April, 2013)
Sidebar: The MISRA Index
C is a very malleable language that allows developers a high degree of flexibility. The downside is that many allowed practices can result in unstructured, hard- to-maintain or faulty code that permits memory overwrites, mismatched types and so forth. MISRA C consists of a list of rules that help d...
(April, 2013)
Decoding MISRA C:2012 for Medtech Applications
The newest version of MISRA lets software developers take advantage of more C features while mitigating risk for medical devices.
(April, 2013)
Unlocking the Potential of Medical Nanotechnology
To succeed as an enabling technology in the medtech sector, nanotechnology must contribute to the development of improved, cost-effective treatments and patient outcomes. Its application in diagnostics, imaging and regenerative medicine shows the way.
(April, 2013)
Medical Packaging Innovators Form a Community
  WORK-AROUNDS HAVE SAVED MY LIFE in publishing more than a few times, but in the medical realm—where lives literally are at stake—they are not always a good idea. This point was brought home during a conversation about sterile medical packaging that I had at MEDTEC Europe....
(April, 2013)
Southeast Asian Economies Build a Harmonised Medical Device Market
The ASEAN Medical Device Directive will establish a uniform medical device registration system for a market of 600 million people.
(March, 2013)
Cardiac Tissue Engineering 2.0
Next-generation heart valve devices, inspired by advances in tissue engineering, could result in new ways of treating heart disease.
(March, 2013)
The Risks and Rewards of Medical Wireless Technology
Patient security, reimbursement and product classification may be speed bumps on the road to widespread wireless connectivity in the medical device space, but make no mistake: the journey has begun, and you don’t want to be left behind.
(March, 2013)
Design for X, and Be Prepared for Anything
To effectively manage the entire lifecycle of a medical product, from creation to end-of-life processing, whilst achieving cost efficiencies, apply DFX principles from the outset.
(March, 2013)
My, What an Ugly Baby!
Design engineers can get so emotionally invested in their projects that they lose all objectivity and deliver an ugly baby that no one wants, least of all the customer. Cross-functional engagement and robust design controls can help to prevent that.
(March, 2013)
Prescribing Operational Excellence in Medical Device Manufacturing
By addressing six concepts of operational excellence, medical device companies can reduce the cost of a product launch, while ensuring the highest standards of quality.
(March, 2013)
Mapping Your Medical Device Launch Strategy
What’s the best launch strategy? Begin marketing your product in the United States or in Europe? This article outlines seven variables for identifying the most effective and profitable option.
(March, 2013)
Keeping Your IP Fit and Healthy
To achieve maximum competitiveness medical device companies should review their intellectual property on a regular basis.
(March, 2013)
Curing the Common Code
The use of modern static analysis has brought long-term best practices to medical software development.
(March, 2013)
Neue Technologien
Winzige Chips retten Leben Winzig kleine Chips können zum Beispiel Patienten, die an einem Aneurysma erkrankt sind, das Leben retten. Entwickelt wird die medizintechnische Innovation zurzeit in einem der bisher größten gemeinsamen Forschungsvorhaben zwischen der TU Hamburg-Har...
(February, 2013)
Branchen-News
Engel-Branchentreff für Medizintechnik-Experten behandelt MedTech-Herausforderungen Einen Tag vor Eröffnung der MEDTEC Europe startet bei Engel der Branchentreff für Medizintechnik-Experten: Am 25. Februar 2013 findet die Engel med.con in Wurmberg statt. Kunden, Partner und In...
(February, 2013)
Memo to EU Member States: Don’t Derail UDI
WELL, THAT WAS FAST. At its March 2013 meeting in Nice, France, the International Medical Device Regulators Forum (IMDRF) announced that it would release guidance on a unique device identification (UDI) system for public consultation in the “near future.” That is usually code for, &ldq...
(May, 2013)
Securing Inside Intelligence Using X-ray Inspection Systems
The increasing complexity of medical devices is driving advances in industrial x-ray technology.
(May, 2013)
Inside the A&D Medical NFC-Enabled Blood Pressure Monitor
Connectivity relies on near field communication technology, which is rarely used in medical applications.
(May, 2013)
US FDA Publishes Proposed Rule on Non-US Clinical Studies
If the proposed rule on US FDA requirements for accepting data from medical device clinical studies conducted outside the United States becomes final, manufacturers will face significant new requirements.
(May, 2013)
Sidebar: The Tenets of Value-Based Selling
Companies that articulate the overall value of a medical product or service have significantly higher customer retention, market share, revenues and profits, according to an Aberdeen Group study of 67 medical device, equipment and diagnostics industry executives. Global consulting firm ZS Associates...
(May, 2013)
Coloplast, Novo Nordisk and 3M among Finalists for MDEA Awards
MD+DI has announced the finalists of the Medical Design Excellence Awards (MDEA), a program honouring the best medical product manufacturers and suppliers, as well as the people behind the scenes. The award ceremony is celebrating its 15th anniversary on 19 June 2013, when the winners will be anno...
(April, 2013)
Sidebar: Extreme Makeover for Medtech Engineers
Go ahead, turn the world on its head. But you're not going to do it alone. After all, Steven Jobs did not invent the iPhone. He preached a vision that drove the Apple team to spectacular success. High-impact engineering for medical devices follows the same model, so get with a team, and lead that t...
(April, 2013)
New US Regulation on CGMPs for Combination Products
US FDA has recently published its long-awaited regulation on current good manufacturing practices (CGMPs) applicable to combination products. The regulation becomes effective on 22 July 2013 and applies to combination products already on the market in addition to newly developed products.
(April, 2013)
Rebuilding the Medtech Engineer
The balance is swinging from high tech to the human touch for medical technology companies, as the emphasis in product development shifts from functionality to regulatory compliance, cost-effectiveness and usability.
(April, 2013)
Pathways to Value-Based Selling and Market Success
Shifting demographics and a challenging economic environment are having a profound impact on the business dynamics of the medical device market in Europe. It’s time to get creative. Four EU companies show how.  
(April, 2013)
Sidebar: The MISRA Index
C is a very malleable language that allows developers a high degree of flexibility. The downside is that many allowed practices can result in unstructured, hard- to-maintain or faulty code that permits memory overwrites, mismatched types and so forth. MISRA C consists of a list of rules that help d...
(April, 2013)
Decoding MISRA C:2012 for Medtech Applications
The newest version of MISRA lets software developers take advantage of more C features while mitigating risk for medical devices.
(April, 2013)
Unlocking the Potential of Medical Nanotechnology
To succeed as an enabling technology in the medtech sector, nanotechnology must contribute to the development of improved, cost-effective treatments and patient outcomes. Its application in diagnostics, imaging and regenerative medicine shows the way.
(April, 2013)
Medical Packaging Innovators Form a Community
  WORK-AROUNDS HAVE SAVED MY LIFE in publishing more than a few times, but in the medical realm—where lives literally are at stake—they are not always a good idea. This point was brought home during a conversation about sterile medical packaging that I had at MEDTEC Europe....
(April, 2013)
Southeast Asian Economies Build a Harmonised Medical Device Market
The ASEAN Medical Device Directive will establish a uniform medical device registration system for a market of 600 million people.
(March, 2013)
Cardiac Tissue Engineering 2.0
Next-generation heart valve devices, inspired by advances in tissue engineering, could result in new ways of treating heart disease.
(March, 2013)
The Risks and Rewards of Medical Wireless Technology
Patient security, reimbursement and product classification may be speed bumps on the road to widespread wireless connectivity in the medical device space, but make no mistake: the journey has begun, and you don’t want to be left behind.
(March, 2013)
Design for X, and Be Prepared for Anything
To effectively manage the entire lifecycle of a medical product, from creation to end-of-life processing, whilst achieving cost efficiencies, apply DFX principles from the outset.
(March, 2013)
My, What an Ugly Baby!
Design engineers can get so emotionally invested in their projects that they lose all objectivity and deliver an ugly baby that no one wants, least of all the customer. Cross-functional engagement and robust design controls can help to prevent that.
(March, 2013)
Prescribing Operational Excellence in Medical Device Manufacturing
By addressing six concepts of operational excellence, medical device companies can reduce the cost of a product launch, while ensuring the highest standards of quality.
(March, 2013)
Mapping Your Medical Device Launch Strategy
What’s the best launch strategy? Begin marketing your product in the United States or in Europe? This article outlines seven variables for identifying the most effective and profitable option.
(March, 2013)
Keeping Your IP Fit and Healthy
To achieve maximum competitiveness medical device companies should review their intellectual property on a regular basis.
(March, 2013)
Curing the Common Code
The use of modern static analysis has brought long-term best practices to medical software development.
(March, 2013)
Neue Technologien
Winzige Chips retten Leben Winzig kleine Chips können zum Beispiel Patienten, die an einem Aneurysma erkrankt sind, das Leben retten. Entwickelt wird die medizintechnische Innovation zurzeit in einem der bisher größten gemeinsamen Forschungsvorhaben zwischen der TU Hamburg-Har...
(February, 2013)
Branchen-News
Engel-Branchentreff für Medizintechnik-Experten behandelt MedTech-Herausforderungen Einen Tag vor Eröffnung der MEDTEC Europe startet bei Engel der Branchentreff für Medizintechnik-Experten: Am 25. Februar 2013 findet die Engel med.con in Wurmberg statt. Kunden, Partner und In...
(February, 2013)
Memo to EU Member States: Don’t Derail UDI
WELL, THAT WAS FAST. At its March 2013 meeting in Nice, France, the International Medical Device Regulators Forum (IMDRF) announced that it would release guidance on a unique device identification (UDI) system for public consultation in the “near future.” That is usually code for, &ldq...
(May, 2013)
Securing Inside Intelligence Using X-ray Inspection Systems
The increasing complexity of medical devices is driving advances in industrial x-ray technology.
(May, 2013)
Inside the A&D Medical NFC-Enabled Blood Pressure Monitor
Connectivity relies on near field communication technology, which is rarely used in medical applications.
(May, 2013)
US FDA Publishes Proposed Rule on Non-US Clinical Studies
If the proposed rule on US FDA requirements for accepting data from medical device clinical studies conducted outside the United States becomes final, manufacturers will face significant new requirements.
(May, 2013)
Sidebar: The Tenets of Value-Based Selling
Companies that articulate the overall value of a medical product or service have significantly higher customer retention, market share, revenues and profits, according to an Aberdeen Group study of 67 medical device, equipment and diagnostics industry executives. Global consulting firm ZS Associates...
(May, 2013)
Coloplast, Novo Nordisk and 3M among Finalists for MDEA Awards
MD+DI has announced the finalists of the Medical Design Excellence Awards (MDEA), a program honouring the best medical product manufacturers and suppliers, as well as the people behind the scenes. The award ceremony is celebrating its 15th anniversary on 19 June 2013, when the winners will be anno...
(April, 2013)
Sidebar: Extreme Makeover for Medtech Engineers
Go ahead, turn the world on its head. But you're not going to do it alone. After all, Steven Jobs did not invent the iPhone. He preached a vision that drove the Apple team to spectacular success. High-impact engineering for medical devices follows the same model, so get with a team, and lead that t...
(April, 2013)
New US Regulation on CGMPs for Combination Products
US FDA has recently published its long-awaited regulation on current good manufacturing practices (CGMPs) applicable to combination products. The regulation becomes effective on 22 July 2013 and applies to combination products already on the market in addition to newly developed products.
(April, 2013)
Rebuilding the Medtech Engineer
The balance is swinging from high tech to the human touch for medical technology companies, as the emphasis in product development shifts from functionality to regulatory compliance, cost-effectiveness and usability.
(April, 2013)
Pathways to Value-Based Selling and Market Success
Shifting demographics and a challenging economic environment are having a profound impact on the business dynamics of the medical device market in Europe. It’s time to get creative. Four EU companies show how.  
(April, 2013)
Sidebar: The MISRA Index
C is a very malleable language that allows developers a high degree of flexibility. The downside is that many allowed practices can result in unstructured, hard- to-maintain or faulty code that permits memory overwrites, mismatched types and so forth. MISRA C consists of a list of rules that help d...
(April, 2013)
Decoding MISRA C:2012 for Medtech Applications
The newest version of MISRA lets software developers take advantage of more C features while mitigating risk for medical devices.
(April, 2013)
Unlocking the Potential of Medical Nanotechnology
To succeed as an enabling technology in the medtech sector, nanotechnology must contribute to the development of improved, cost-effective treatments and patient outcomes. Its application in diagnostics, imaging and regenerative medicine shows the way.
(April, 2013)
Medical Packaging Innovators Form a Community
  WORK-AROUNDS HAVE SAVED MY LIFE in publishing more than a few times, but in the medical realm—where lives literally are at stake—they are not always a good idea. This point was brought home during a conversation about sterile medical packaging that I had at MEDTEC Europe....
(April, 2013)
Southeast Asian Economies Build a Harmonised Medical Device Market
The ASEAN Medical Device Directive will establish a uniform medical device registration system for a market of 600 million people.
(March, 2013)
Cardiac Tissue Engineering 2.0
Next-generation heart valve devices, inspired by advances in tissue engineering, could result in new ways of treating heart disease.
(March, 2013)
The Risks and Rewards of Medical Wireless Technology
Patient security, reimbursement and product classification may be speed bumps on the road to widespread wireless connectivity in the medical device space, but make no mistake: the journey has begun, and you don’t want to be left behind.
(March, 2013)
Design for X, and Be Prepared for Anything
To effectively manage the entire lifecycle of a medical product, from creation to end-of-life processing, whilst achieving cost efficiencies, apply DFX principles from the outset.
(March, 2013)
My, What an Ugly Baby!
Design engineers can get so emotionally invested in their projects that they lose all objectivity and deliver an ugly baby that no one wants, least of all the customer. Cross-functional engagement and robust design controls can help to prevent that.
(March, 2013)
Prescribing Operational Excellence in Medical Device Manufacturing
By addressing six concepts of operational excellence, medical device companies can reduce the cost of a product launch, while ensuring the highest standards of quality.
(March, 2013)
Mapping Your Medical Device Launch Strategy
What’s the best launch strategy? Begin marketing your product in the United States or in Europe? This article outlines seven variables for identifying the most effective and profitable option.
(March, 2013)
Keeping Your IP Fit and Healthy
To achieve maximum competitiveness medical device companies should review their intellectual property on a regular basis.
(March, 2013)
Curing the Common Code
The use of modern static analysis has brought long-term best practices to medical software development.
(March, 2013)
Neue Technologien
Winzige Chips retten Leben Winzig kleine Chips können zum Beispiel Patienten, die an einem Aneurysma erkrankt sind, das Leben retten. Entwickelt wird die medizintechnische Innovation zurzeit in einem der bisher größten gemeinsamen Forschungsvorhaben zwischen der TU Hamburg-Har...
(February, 2013)
Branchen-News
Engel-Branchentreff für Medizintechnik-Experten behandelt MedTech-Herausforderungen Einen Tag vor Eröffnung der MEDTEC Europe startet bei Engel der Branchentreff für Medizintechnik-Experten: Am 25. Februar 2013 findet die Engel med.con in Wurmberg statt. Kunden, Partner und In...
(February, 2013)

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