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Europe: Medical Device Incident Repor…
Each year, the regulatory authorities receive several hundred thousand medical device reports of susp…
Brazil – General Provisions for…
ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out stabi…
China’s CMDE Announces New Regulation…
The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 53) th…
An Overview of European Unique Device…
The Medical Device Regulations (EU 2017/745, EU 2017/746) introduce the Unique Device Identification …
Medical Device Post Market Surveillance
The post-market surveillance (PMS) systems that monitor medical device safety after launch reduce bot…
Why is Medical Technology Getting Shr…
Cybersecurity threats top the list when it comes to imminent dangers surrounding the healthcare indus…
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