• 주제: IVDR Lessons Learnt (IVDR 인증 준비 노하우)
• 일시 (한국시간): 5월 12일 10pm – 13일 1am (3시간)
• 발표자:

  Dr Erica Conway – Global Head, In Vitro Diagnostic, Regulatory Services

  Dr Liz Harrison -Technical Team Manager, In Vitro Diagnostic, Regulatory Services

  Judith Prevoo – Regulatory Lead

  Dr Heike Möhlig-Zuttermeister – Technical Team Manager, In Vitro Diagnostic, Regulatory Services

세미나는 미리 등록하셔야 하며, 등록하실 경우 (또는 시차로 인해 참여하시지 못하시더라도) 녹화된 비디오 및 프레젠테이션 자료를 추후 받으실 수 있습니다. 신청은 아래 버튼을 눌러 하실 수 있습니다. 세미나 종료 후 자료 다시 받기 신청하시면 자료를 받아보실 수 있습니다.  

웹세미나 상세보기

5월 12일 – 13일: 웹세미나 등록하기 

지난 IVDR 웹세미나 동영상 다시보기

Webinar: In Vitro Diagnostic Regulation (IVDR) Lessons Learnt

Date: 12 May 2021 – 13 May 2021 (Korean time)

Time: 22:00 – 01:00 (Korean Time), 14:00 – 17:00 (UK time)

What’s this webinar about?

The In Vitro Diagnostic Regulation (IVDR) date of application is fast approaching. Manufacturers have the transition period’s duration to complete their Technical Documentation to meet the requirements and comply with the Regulation before the Date of Application of the IVDR in May 2022.

The timelines for ensuring your product maintains EU market access under the new, more stringent IVDR, are challenging.

BSI Notified Body would like to share some of our experiences and lessons learnt around the application process. The IVD Team will provide helpful information for updating your Technical Documentation.

Who should attend the webinar?

This webinar will offer notified body insights for all people involved in working towards an IVDR application, whether you are a novice or have significant experience of working with a notified body.  

What will participants gain?

Join this insightful extended webinar to hear from Dr Erica Conway, BSI’s Global Head of IVD Medical Devices, talk about IVDR lessons learnt so far, as well as tips on making applications and the Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR). This is a special extended webinar and Dr Conway will also be joined by subject matter experts, Dr Liz Harrison, Dr Heike Möhlig-Zuttermeister and Judith Prevoo.

The webinar will include:

–          How best to achieve certification with a Notified Body.

–          Lessons learnt around making applications, device schedules/transitions and grouping.

–          QMS audit lessons learnt.

–          General lessons learnt on Technical Documentation reviews.

–          Specifics on Performance Evaluation and technical findings.

–          Questions panel and Q&A session. We encourage you to submit questions in advance of the webinar with your registration. Please submit any questions to https://bit.ly/3fb2zxz

You will also have the opportunity to submit questions on the day.