Kobridgeconsulting.com

Medical Device Cybersecurity

WEBStrategies to Improve Medical Device Security. To improve medical device cybersecurity, manufacturers can implement secure communication, data protection, device integrity, …

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URL: https://kobridgeconsulting.com/medical-device-cybersecurity/

Medical Device Single Audit Program (MDSAP) Kobridge

WEBThe pilot phase ended December 2016 and the formal program begun January 2017. The MDSAP program is intended to allow MDSAP recognized Auditing Organizations to …

Category: Health Go Health

Medical Device Classes Kobridge

WEBClass II is further divided into Class IIa and Class IIb, where the former is only for medium risk devices and the latter is for medium/high-risk devices. Class III is only allocated to the highest-risk medical devices. The medical device classification system by the EC is very similar to the U.S. FDA classification.

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Class III Medical Device Kobridge

WEBAccording to the PMA, class III is the most intensive type of device needed by the FDA. Some devices are exempted and must qualify for a 510 (K) filing, but many of them need …

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Software as a Medical Device (SaMD) Kobridge

WEBSoftware as a Medical Device (SaMD) is an innovative trend in healthcare. SaMD software bridges the gap between medical devices and information technology, using software to …

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South Korea KGMP inspection requirements

WEBRisk management file. Here is a table of reference summarizing the requirements: 1」Manufacturers that have had KGMP non-compliance issues within three years or that …

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EU MDR harmonized standards

WEBEU MDR harmonized standards first set released. The manufacturer must justify and document the design steps of his device. He must verify compliance with the …

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Medical Device Consulting – Regulatory & Quality Kobridge

WEBMedical Device consultingQuality & Regulatory. Kobridge is a medical device consulting firm expert in regulatory affairs. and quality system. We cover global market submissions. Kobridge is helping medical device companies since 2007. View Details. 15 YEARS OF EXPERIENCE. BEST INDUSTRY EXPERTS.

Category: Medical Go Health

Korean Health Industry market

WEBKorean Health Industry market over the past decade has shown a growth of more than twice.Exports also increased more than four times as per 2013 record of $ 5.76 billion …

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EU MDR UDI requirements for manufacturers Kobridge

WEBThe MDR will enter into force on 26 May 2021. According to the UDI requirements, the device labelers – typically the manufacturers – are required to: include a UDI on device …

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MFDS guidelines STED

WEBSouth Korea. MFDS guidelines STED. Aug 26 2015. South Korea. MFDS recently revised its handbook in order to align with STED guidance from International Medical …

Category: Medical Go Health

Medical Device Post Market Surveillance in Canada

WEBSignal detection and assessment. Health Canada continuously receives and evaluates Medical Devices Incident Reports and Post-Market Adverse Reaction Reports. Through …

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Canada Medical Device Registration

WEBClass II, III, and IV medical devices offered for sale in Canada require a medical device license. To successfully apply for a medical device license the manufacturer must …

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Medical Device Consulting Services Regulatory & Quality

WEBISO 9001 – Quality management systems. Medical Device Consulting Services are extended to this standard which can useful for distribution activities. ISO 13485, Medical …

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PreMarket Medical Devices in Canada

WEBLabeling Requirements. Medical devices without a compliant label must not be sold or imported. Pre-Market Medical Devices in Canada labeling requirements are as follows: …

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