Person Responsible for Regulatory Compliance
The Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices and IVDs present a new obligation for manufacturers and EU Authorised Representatives to appoint at least one Person Responsible for Regulatory Compliance (PRRC). Article 15 of both these Regulations provides a detailed description of the qualifications the PRRC must have and their minimum responsibilities. The ...
Cybersecurity
Cybersecurity is an important aspect of any medical device which incorporates software. Such devices can be vulnerable to various cybersecurity threats, resulting in health-related, privacy, economic and reputational risks. As the medical device industry is gravitating more towards digital healthcare applications, the risk of cybersecurity attacks is on the rise and as such there is ...
Software as a Medical Device
Software within the healthcare industry is exploding with innovation so much so that regulation is only now starting to catch up!, making software key to a medical device revolution. Software is now incorporated within many medical devices including smartphones. This means that such software and applications must abide by the relevant EU legislation and must ...
EN ISO 62304: 2006 Medical Device Software Validation
The topic of software validation is one that continues to cause confusion, so we have developed a series of flowcharts to help clarify the requirements. These cover: * EN ISO 62304; 2006 medical device software – software life cycle processes * FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff Please ...
