newsletter - March 2024
Fabiola Hartung-Linz
??#1 | MEDTECH | MDR | IVDR | QMS | AI | REGULATORY&CLINICAL AFFAIRS | SOFTWARE | MEDICAL APPS & DiGA | DIGITIZATION | CYBERSECURITY | ESG/CSR |?+491733296833 | [email protected] | ??LOVE TO SUPPORT YOU??
The AI Act is (almost) here!
In part 2 of our series on artificial intelligence in medical technology, we looked at the topic of “Regulatory requirements”. We mentioned some of the standards on artificial intelligence and the committees involved. On 9 March 2021, the European Commission presented its goals for the digital transformation by 2030. In order to achieve these goals, more and more legislation on AI and digitalisation is being published, which poses a major challenge for research and development teams.
Quality standard ISO 13485
Quality is the degree to which a set of inherent characteristics of an object fulfils requirements.
ISO 13485 is an international standard for quality management systems that comprehensively defines such requirements for organisations that develop, manufacture and distribute medical devices.
Risk management according to ISO 14971:2019 – what’s new?
12 years is a long time. A time in which medical technology has revolutionized. Time to publish the third edition of the standard for risk management for medical devices, ISO 14971. It will be published in December 2019 and harmonized in May 2022.
领英推荐
19. - 20. March 2024 | Vogel Convention Center | Würzburg
?? Credit code EXPERTTALKS24_MEETME means 100 Euro cost down for you!
Speaker seleon:
Karin Berndt (Ich wei?, was du letzten Sommer (nicht) getan hast! – Die MDR (EU) 2017/745 und ihre Frist?nderungen 2023 - k?nnen wir alle Fünfe bis 2028 gerade sein lassen?)
and
Peter Hartung (Regulatory Cybersecurity Affairs – Was ist das und warum ist es so wichtig?)
Link: RA Expert Talks
We will visit DMEA on 9th - 10th of April 2024 - for an appointment please send us an LinkedIn note.
See you soon in Berlin!
Link: DMEA