Cyber Security Plan for Software as Medical Device

Cyber Security Plan for Software as Medical Device(SaMD) become more competent in accessing, analyzing, communicating, and automation to improve the speed and quality of patient care. However, advancements with technological advances arise new risks and concerns. The risk of threats in both network and software is unavoidable through hackers. To assist manufacturers in developing adequate…

506J Notification

What is FDA’s Section 506J Notification? Section 506J notification of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of specific devices or an interruption in the manufacture of certain devices, which leads to disruption in the supply of that device in the United States. This policy is…

MDR Classification

MDR Classification

Medical Device Classification The new MDR 2017/745, which came into effect on 26 May 2021, categorizes medical devices into classes: Class I, Class II a, class II b, and class III. This classification is based on the 22 rules in the new MDR 2017/745. Rules 1-4 for Non–invasive devices, rules 5-8 for Invasive devices, rules 9…

CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE

Chemical Characterization of Medical Devices

EN ISO 10993-18 ( CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE )     Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractable and leachable) which could disclose biological risks to patients and medical practitioners. Extractables are substances that can be…