We are excited to announce that RegDesk, the innovative Regulatory Information Management (RIM) platform, has been recognized as a Representative Vendor in the Gartner® Market Guide for Life Sciences Regulatory Information Management. Read the complimentary Market Guide for RIM Solutions report to learn more!
The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
The new article addresses the matters related to labeling requirements the devices should comply with in order to be allowed for marketing and use in the country. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
The new article highlights the aspects related to biocompatibility, electrical safety, electromagnetic compatibility, and the use of wireless technologies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
The new article describes in detail the aspects related to comparison to similar medical devices already placed on the market and also outlines the scope of information to be provided with respect to the software used to operate such devices. Table of Contents The...
The article provides an overview of the applicable regulatory requirements and describes the policy the authority intends to apply. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...