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management, and use of safe and effective
health technology in the United States. For
details on standards, training and events,
please follow the link: www.aami.org
https://eur03.safelinks.protection.outlook.com
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. Questions about standards should be sent to
standards@aami.org
mailto:standards@aami.org.
public 7:02 AM
Full time group of investigation clinical and non clinical human safety factors professional
Take statements of people to investigate for safety
Investigations. Be open safety investigations tell a lot
of deficiencies in the system. Whole system in place
That can take action in this. We need to close the circle.
Safety recommendations. Mitigated by the actions.
Which investigations? 4 criteria serious harm: systemic in
Nature. Ask ourselves which is the benefit of hsbi. Escrutiny
In an intelligence panel. Ho is the most important person
To make thesafety recommendation.
To hear NHS incident data base. WEB site.National Safety investigation body before NEVER.
HSBI Will have a program of professionilizinf safety investigations. 12 hr online NHS . Formal
methodology there are many to use many trained investigators to use the most
appropriate. SEEDs safe engineering try to identify all the factors. The biggest system
How do we accelerate standardization? A challenge in global context. In terms of ISO
delivered standards. Joint Ventures in standardizations. We are produceing guidance not at
a 100%. Listening to the feed back. 27 years a standard for oxygen ventilators.
Manufacturer has to dec ide which
standard to adopt even if it is harmonised
If not direct to the european
Community.
20417 can be used as reference for IVD´s. Technical committe takes longer in systematical
Reviews.

Conferences Team - Technical Support

(Organizer)to Everyone Stay up-to-date on the
new Medical Devices / IVD Regulations and
innovations in the medical device industry with
BSI Medical Device blog
https://compliancenavigator.bsigroup.com/en/
community/blog-page/
 Conferences Team - Technical Support (Organizer)to Everyone BSI as the National Standards
Body in the United Kingdom manages the standards development program and is keen to
recruit new members to their committee’s, individuals with competency and expertise are
always welcome to join and use their experience to help develop standards which can be
adopted and used by others. If you are interested in joining or have a conversation to explore
what is required, please email: standardsmakers@bsigroup.com

AAMI leads global collaboration in the development, management, and use of safe and
effective health technology in the United States. For details on standards, training and events,
please follow the link: www.aami.org. Questions about standards should be sent to
standards@aami.org.
Conferences Team - Technical Support (Organizer)to Everyone Stay up-to-date on the new
Medical Devices / IVD Regulations and innovations in the medical device industry with BSI
Medical Device blog https://compliancenavigator.bsigroup.com/en/community/blog-page/