Developing connected and software-enabled medical device cybersecurity based on regulatory recommendations

FDA 2020 medical device user fees take effect October 1, 2019

New PMSR compliance deadlines for combination product manufacturers

The term Internet of Things (aka IoT ) entered the lexicon in 1999. Since then,...

New standard for medical device and software interoperability to help meet FDA cybersecurity requirements

Brazilian medical device market regulator ANVISA has begun requiring manufacturers and sponsors to provide field...

The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards,...

TGA guidance in line with cybersecurity requirements from US, Canadian, South Korean regulators

The National Medical Products Administration (NMPA), China’s medical device market regulator, has begun laying the...

NB capacity to support CE Mark certification under current Directives, future Regulations squeezed further.

Further details related to MEDDEV 2.12-1 rev. 8 under the European Medical Devices Directive (MDD).

Tips for human factors validation study investigators recruiting representative user participants

New guidance clarifies PRRC role under the new Regulations

Additional details on China’s new electronic registration system

The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device...