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Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

Here Come the Exoskeletons

My colleagues and I are excited by the current value and future potential of exoskeletons in healthcare. Applications of particular interest are the accommodation and treatment of partial paralysis and other types of musculoskeletal impairments, some of which are caused by a stroke.

New South Korean Guidelines for Medical Device Cybersecurity Management

EMERGO SUMMARY OF KEY POINTS:

  • South Korea’s Ministry of Science and ICT has published new guidelines for medical device cybersecurity risk management.
  • The guidelines reference UL 2900, US FDA cybersecurity guidance and related standards and recommendations in place in other medical device markets.

Règlements UE - DM et DIV : publication des instructions d'utilisation sur les sites Web des fabricants

Par Ronald Boumans

LES POINTS PRINCIPAUX PAR EMERGO :

  • Le RDM (ou RIM) et le RDIV européens exigent que les fabricants de dispositifs médicaux publient sur leurs sites Web les informations destinées aux utilisateurs.
  • La publication des informations destinées aux utilisateurs sur le site Web d'un fabricant rend le règlement (UE) 207/2012 sur les instructions d'emploi électroniques applicable.
  • La règlementation concernant les instructions d'emploi électroniques (e-labeling) ne s'appliquent qu'aux dispositifs médicaux, pas aux DIV.
  • Cette simple exigence peut avoir des conséquences sur les systèmes de gestion de la qualité des entreprises ainsi que sur leurs accords avec les importateurs et les distributeurs.

New South Korean Guidelines for Medical Device Cybersecurity Management

EMERGO SUMMARY OF KEY POINTS:

  • South Korea’s Ministry of Science and ICT has published new guidelines for medical device cybersecurity risk management.
  • The guidelines reference UL 2900, US FDA cybersecurity guidance and related standards and recommendations in place in other medical device markets.