Is your software a medical device?

International – Is your software a medical device?

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This...
Brazil's ANVISA launching Notification pathway for low-risk medical devices and IVDs

Brazil – Brazil’s ANVISA launching Notification pathway for low-risk medical devices and IVDs

Brazilian regulators have published RDC 270/2019 establishing a notification pathway for Class I medical devices and IVDs Qualifying low-risk medical devices will not...
Transition to ISO 13485:2016 Comes to an End

International – Transition to ISO 13485:2016 Comes to an End

The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless...
A Look at the Competitive Landscape of Diabetes Devices

International – A Look at the Competitive Landscape of Diabetes Devices

Diabetes represents a huge market opportunity for medical device companies, but that also makes for a tough competitive landscape. Here we have reviewed the...
Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices

India – Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical...

India has become the latest medical device market whereby regulators have begun accepting electronic indications for use (eIFU) for registrations. Manufacturers can realize...
WHO Advances International Harmonized Nomenclature for Medical Devices

International – WHO Advances International Harmonized Nomenclature for Medical Devices

The World Health Organization (WHO) reported Monday on recent progress toward the development of its international nomenclature for medical devices, known as the International...
Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?

International – Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?

Manufacturers whose intended users include children must consider pertinent human factors and usability issues when designing their medical devices. Issues pertaining to working...
Human Factors Engineering and Usability: What you should know about diary studies

International – Human Factors Engineering and Usability: What you should know about diary studies

Use of diary studies as tools for human factors research and design applications increasing Diary studies providing more efficient access to longitudinal data “Dear...
New Israeli fund to support medical device development

Israel – New Israeli fund to support medical device development

The Assuta chain of medical clinics and private hospitals, controlled by Maccabi Health Services with a 95% stake, has founded a venture capital fund...
CE Mark suspended for Endologix Nellix stent graft

International – CE Mark suspended for Endologix Nellix stent graft

Endologix (NSDQ:ELGX) said yesterday that the CE Mark approval for its Nellix stent graft system designed for treating abdominal aortic aneurysms was suspended by its notified...

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