The need to ensure that medical devices are designed, manufactured and also used in a way that does not lead to unnecessary risks to patients and users is not new. This need is addressed in a broad manner in the general Essential Requirements of all three ...

this report makes recommendations for improving the regulation of digital medical devices.

Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally ...

In many cases HAIs are attributed to in-dwelling medical devices, such as wound dressings ... a scalable current good manufacturing practice (cGMP) process with defined lead times.

There are several categories of medical devices, each with its own unique set of regulations and guidelines. Class I devices are low-risk devices such as bandages and tongue depressors ...

Medical devices can be tested ... to demonstrate that the device meets its design specifications. Clinical trials may follow. Testing for regulatory approval, to meet the stated or implicit requirements of one or more regulatory agencies, is performed ...

Medical devices imported into Canada for sale, with or without a monetary contribution, must meet Health Canada requirements for commercial importation, as outlined in the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR). The importation ...

The US Federal Drug Administration (FDA) has issued guidelines for the security of connected medical devices which will force medical device manufacturers to implement set of practices ensuring the security of medical devices from cyber-attacks and ...

Engineering for medical, automotive, and aerospace is highly regulated. It’s not difficult to see why: lives are often at stake when devices in these fields fail. The cost of certifying and ...

Researchers at Manchester who are considering carrying out research that will involve a medicine or involve the use of a medical device must seek guidance from the MHRA and from our Research Governance, Ethics and Integrity webpages on StaffNet.

issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances, advice and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a ...

Companies in the global mHealth monitoring diagnostic medical devices market are undergoing strategic acquisitions which enable product distribution in various regions and also strengthen their global presence. Rise in demand for technology-driven ...

The COVID-19 pandemic highlighted the inadequate availability of essential medical devices in India during a time of intense demand. Medical devices, ranging from ventilators and oxygen purifiers to personal protective equipment (PPE) and N95 masks ...

The healthcare sector is not homogeneous, its companies and sub-sectors are diverse. In contrast, the business activities and products of most banks look similar and it’s easy to compare one bank to another. This just isn’t the case with healthcare ...

Today we are pleased to announce that Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements.

The state-of-the-art quality control and research and development laboratory in Balerna, Switzerland is run by APR Applied Pharma Research SA, a Relief Therapeutics subsidiary. GE

One of the most important events for pharmaceutical packaging and drug delivery in Asia is CPhI China. It will

Novo Nordisk Pharmatech has entered an agreement with Azelis for the distribution of quaternary ammonium compounds (quats) to the

Many impressive and intricate medical devices help make health care efficient. From robotics to implantable devices, medical devices can treat conditions, assist in everyday activities ...