2018년 4월4일에 식품의약품안전처 주관으로 개최되었던 2018년도 의료제품 분야 국가표준 전문가 워크샵에서 발표했던 자료입니다. 의료 제품 분야에 ICT 기술이 결합되어야 하는 시대에, 어떤 표준화 이슈가 있고, 현재 국제표준화 기구에서의 대응이 어떻게 진행되고 있는지, 그리고 한국의 역할은 어떤지를 정리하였습니다. 나아가 4차산업혁명 시대에 의료기기 제품 개발을 위해 표준과 규제가 어떻게 함께 조화롭게 대응이 필요한지까지 언급 해보았습니다.
혹시 수정보완 등이 필요한 부분이 있으면 언제든 코멘트 남겨주시기 바랍니다.
19. The 1st Wave
The 2nd Wave
The 3rd Wave
Big Waves in ICT worldBig Waves in ICT world
Digitalizing
Cyber Space
Hyper Connectivity
Super Intelligence
The ICT waves generated huge tsunami waves
20. The 2nd ICT Wave – “Cyber Space” withInternet,Broadband,WWW
Broadband Access
Internet
Now we are living in ”Cyber Space”
21. The 2nd ICT Wave – “Cyber Marketplace”
The value of intangible makes Money !
No Create Contents No Own Taxi
No Real HousesNo Inventory
25. The 3rd ICT Wave – “Hyper Connection Super Intelligence”
Smart Devices
Cloud Computing Big DATA
+
Expansion of Hyper Connection between
Physical space Cyber space
Adding the intelligence makes Big Impact !
Internet of Things Artificial Intelligence
33. Misuse of technology brings DisasterMisuse of technology brings Disaster
Some thoughts for ArtificialIntelligence
34. How What Standardsneeds to be consider ?How What Standardsneeds to be consider ?
Internet of ThingsInternet of Things
SecuritySecurity
Hybrid CloudHybrid Cloud
Big DataBig Data
Artificial IntelligenceArtificial Intelligence
Smart X
39. Some considerations for
the future STANDARDS in the era of
the forth Industrial Revolution
Some considerations for
the future STANDARDS in the era of
the forth Industrial Revolution
40. The era of 4th Industrial Revolution
Complex Conformance InteroperabilityComplex Conformance Interoperability
POINT #1
41. “System Integration Standards”
The era of 4th Industrial Revolution
POINT #2
Emerging for Human being more
BIO centric ICT with new disruption
42. The era of 4th Industrial RevolutionThe era of 4th Industrial Revolution
POINT #3
Open Source
Fast Prototyping Implementation
50. POINT #6 Connected Healthcare
Internet of Things
Internet of
Medical
Things
IoT Framework open source
(OCF)
Safety Performance Requirements for
Medical Electrical equipment
(IEC)
Medical
Devices
*40*$ Y