So you are looking for complying ISO 14644 standard for clean room! If you are into the medical industry, or if your work nature is into the commercial, medical or industrial industry, then you should know about the Clean Room, where every medical industry must work under “clean” conditions, as an extremely small dust particle […]
ISO 14644 Standard – Why Is It Necessary for Your Clean Room? Read More »
The Australian healthcare system is compounded with a blend of public and private sector health service providers with a scope of financing and regulatory components including three levels of government; the Australian, State/Territory, and Local. The Australian Government has the essential part of developing broad national policies (especially in national issues like public health, research
Australian Regulators Plan Improved Patient Access | Prosthetic Medical Devices Read More »
The healthcare industry also called the medical industry is the scope of organizations and non-benefit organizations that give medicinal services, medical device manufacturer etc. The healthcare industry is going through a transformation, and to achieve success in this growing competitive environment, organizations need to make notable investments in processes and technologies to improve medical care.
Design History File vs 510(k) vs Technical File Read More »
Overview of Software Validation Requirements It’s high time when you need to be persuaded about the working capability of your system and also that it continues to work in the manner required. With the arrival of updates for ISO 13485: 2016, organizations had been obligated to look for transition in QMS being used. This compliance
Better Insights For ISO 13485: 2016 Software Validation Requirements Read More »
On a recent visit to BDO in Norway, it struck me that many South African-based businesses and organizations are increasingly exposed to cyber threats and vulnerabilities of which they are blissfully unaware and also need to learn about the South African Cyber Security. There is no doubt that we currently find ourselves in an age
South African Firms lead to Cyber Threats | Cyber Security Read More »
Imagine stepping into a hospital outpatient clinic or polyclinic and skipping the long wait, just by looking into a camera. It is a facial recognition device which is able to match a patient to his or her medical and personal data. There is no manual registration or paperwork to be done. A text message will tell the patient which consultation
Artificial Intelligence Launched New System For Singapore Hospitals For Patient Data Read More »
Medical Device Registration in Saudi Arabia Saudi Arabia is a monarchical state with large oil reserves and is one of the leading members of OPEC. It is an oil-based economy and the government controls most major economic activities. Due to the low oil prices, the government is focusing on expanding its healthcare, education, nuclear, construction,
Medical Device Registration in Saudi Arabia Read More »
Manufacturers of combination products were offered a list on Tuesday of adaptable components that can be utilized to agree to the FDA US (Food and Drug Administration’s) necessities for Good Manufacturing Practices(GMP).The proposal satisfies a mandate from the 21st Century Cures Act of 2016 that approached FDA to periodically issue a rundown recognizing the types of combinations
FDA Proposes Mechanisms to Comply with GMP’s Requirements Read More »
Recently, the US FDA (Food and Drug Administration) published two guidances which its intended use was to clarify its strategies on communicating (Medical Product Communications) the medical product data to payors and to inform the industry on the best way to convey data about products in a reliable way with FDA-required labelling. This guidance shows
FDA Releases Draft Guidance for Medical Product Communications | Labeling Read More »
This is the most recent move in the FDA’s attention on medical device software, for medical devices safety which started in the year 2002 when the agency published its Guidance on Software Validation. Since that time, the utilization of software in medical devices has expanded and turned out to be more complex. The FDA has moved towards
FDA focuses on the Medical Devices Safety | Cybersecurity Read More »
