MDCG 2022-21: Requirements for Preparation of the Periodic Safety Update Reports
The long awaited MDCG 2022-21 has been finally published and preparation of the Periodic Safety Update Report became much easier.…
ISO 11138 Family of Standards: Requirements for Biological Indicators
ISO 11138 is a crucial standard in the field of sterilization, specifically focusing on the validation of sterilization processes for…
Cybersecurity Risk Assessment
Cybersecurity risk assessment is a systematic process of identifying, analyzing, and evaluating potential threats and vulnerabilities that could compromise the…
ISO 80369-1: An Essential Guideline to reach Compliance
ISO 80369-1 entitled “Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements” specifies the design,…
Vulnerability Disclosure: Overview of Main Requirements
In today’s digitally connected healthcare landscape, the integration of medical devices with networked systems and electronic health records has revolutionized…
Process Validation Series: Installation Qualification
In regulated industries like medical device manufacturing, ensuring product quality and compliance with stringent regulatory standards is paramount; within the…
ROHS Compliance: An essential Guideline for Medical Device Manufacturers
RoHS compliance has become a focal point for companies worldwide, shaping their production methods and product design to align with…
ISO 27001 Scope Template: A Practical Guideline
One of the most important document related to ISO 27001 is related to the definition of the scope of an…
ISO 14971 : Risk Management for Medical Devices
The approval of ISO 14971 for medical device risk management in December 2019 marked a significant milestone in ensuring the…
ISO 27001 Vulnerability Assessment
In the intricate realm of information security, where digital landscapes evolve and cyber threats loom large, the ISO 27001 standard…
