Medical Device Cybersecurity

medical device cybersecurity

Keeping Your Medical Devices Safe with the Latest Cybersecurity Solutions In the ever-changing world of medical devices, one thing is for sure: the FDA and other regulators have been taking a much closer look at what needs to be done in order to keep patients safe in this connected world. In fact, the FDA’s guidance…

samd

SAMD

“Software as a Medical Device (SaMD)” – A New Trend in Healthcare Software 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 improve patient care. It has been growing steadily over the past few years, but only recently have…

class iii medical device

Class III Medical Device

Class III Medical Device A series of medical devices are available on the market, and are classified into different sub-categories like Class I, Class II, and Class III devices. As per “the Food and Drug Administration,” the medical devices are classified into these three categories. Out of which, you will get to know about Class…

ISO 13485 pdf

ISO 13485 pdf

Free access to ISO 13485 standard, other medical device and personal protection equipment standards To sustain the campaigns taking care of the impact of COVID-19, the International Organization for Standardization (ISO) has made a few of its standards supporting the assessment of medical devices as well as personal protection equipments used in healthcare setups easily…

Korea FDA

Korea FDA

Responsible Authorities in Korea FDA Medical devices in South Korea are managed by Medical Device Act and controlled by The Ministry of Food & Drug Safety (MFDS) or formerly Korea FDA. Under the jurisdiction of the Act, requirements for medical devices are provided in numerous various titles of guidelines. Below is a list of the…

EU MDR Post-Market Surveillance

EU MDR Post-market surveillance

EU MDR Post-market Surveillance System The European Medical Device Regulation 2017/745 requires establishing a post-market surveillance system once the medical device is on the market. The EU MDR Post-Market Surveillance requirements will be explained below: PMS system is established for the following: For each device: variants can be grouped for a device but the PMS…

EU MDR Technical Documentation

EU MDR Technical Documentation

EU MDR Technical Documentation Summary The European Medical Device Regulation 2017/745 requires the compilation of technical documentation. See below a summary of the information to be included to comply with EU MDR Technical Documentation. The manufacturer shall develop technical documentation for each of its devices[1]. The technical documentation must be such that it allows the…

EU MDR UDI

EU MDR UDI

Definition of UDI from the MDR EU MDR UDI has been introduced and even though it may not be new for those selling medical devices in USA, it is a new requirement to achieve the CE marking of a medical device. The European Medical Device Regulation 2017/745 defines the UDI as follow: (15)‘Unique Device Identifier’…

EU MDR clinical evaluation

EU MDR clinical evaluation

EU MDR clinical evaluation EU MDR clinical evaluation requirements are quite overwhelming. There are a lot of requirements and the strategy to achieve conformity is not always clear. We cover those requirements in detail. In order to show conformity with general requirements in terms of safety and performance to determine adverse effects and to evaluate…

EU MDR risk management

EU MDR risk management

EU MDR risk management EU MDR risk management requirements can be implemented with the help of the harmonized standard EN ISO 14971. The manufacturer must ensure risk management activities are carried out. He must update it periodically and systematically throughout the life cycle of each device[1]. In order to ensure risk management, the manufacturer must:…