Webinar - Mastering risk management for EU MDR

Join our webinar to explore recent findings in Technical Documentation (TD) related to risk management for Medical Device Regulation (MDR) compliance.

This upcoming webinar titled "Mastering risk management for EU MDR: Technical documentation, GSPR, and compliance insights" will be focusing on the Technical Documentation (TD) related to risk management for Medical Device Regulation (MDR) compliance.

Our expert will guide manufacturers and economic operators in addressing gaps and common pitfalls within Quality Management Systems (QMS) and TD, as well as the terminology in risk management for QMS MDR and TD submission.

 

Webinar agenda:

  • Introduction to risk management for EU MDR.
  • Technical Documentation (TD) requirements for risk management.
  • General Safety and Performance Requirements (GSPR) 1.
  • General Safety and Performance Requirements (GSPR) 2-5 & risk management.
  • Key articles and annexes mentioning risk management.
  • SPR 3 - ISO 14971:2019 (TR 24971).
  • Frequent gaps in technical documentation and QMS during MDR certification.
  • Interface and alignment of risk management with MDR.
  • Q&A session.

We look forward for your participation.

 

Our speaker:

Ramaya Thillainathan

Medical Device Lead Auditor and Assessor, Supply Chain & Product Assurance

DNV

 

 

This upcoming webinar titled "Mastering risk management for EU MDR: Technical documentation, GSPR, and compliance insights" will be focusing on the Technical Documentation (TD) related to risk management for Medical Device Regulation (MDR) compliance.

Our expert will guide manufacturers and economic operators in addressing gaps and common pitfalls within Quality Management Systems (QMS) and TD, as well as the terminology in risk management for QMS MDR and TD submission.

 

Webinar agenda:

  • Introduction to risk management for EU MDR.
  • Technical Documentation (TD) requirements for risk management.
  • General Safety and Performance Requirements (GSPR) 1.
  • General Safety and Performance Requirements (GSPR) 2-5 & risk management.
  • Key articles and annexes mentioning risk management.
  • SPR 3 - ISO 14971:2019 (TR 24971).
  • Frequent gaps in technical documentation and QMS during MDR certification.
  • Interface and alignment of risk management with MDR.
  • Q&A session.

We look forward for your participation.

 

Our speaker:

Ramaya Thillainathan

Medical Device Lead Auditor and Assessor, Supply Chain & Product Assurance

DNV