2018 Annual BSI Medical Devices Updates

Agenda

Time

  

Speaker

0900 

Registration and refreshment

 

 

0915 

Welcome and Introduction

 

Nicklaus Au, Training Business Manager

BSI Malaysia

0930 

MDR & IVDR Update

  • Transitional arrangements
  • Technical documentation
  • Classification updates / changes
  • MDR & IVDR Conformity assessment
  • Clinical evidence and clinical evaluation / performance evaluation
  • PMS (post market surveillance) and PMCF  / PMPF (post market clinical / performance follow-up)

Hailey Chu, IVD Technical Specialist

BSI Taiwan

1030 

Refreshment

1045 

Personal Protective Equipment (PPE) Regulation Update

  • Introduction of the PPE Regulation (EU) 2016/425
    • Compliance  and implication on Manufacturers
    • Classifications
  • Changes in MDD/MDR to allow dual certification
  • Dual CE marked PPE and Medical products

Nathan Shipley, PPE Group Certification Manager

BSI UK

1130 

Medical device single audit program (MDSAP) Update

Liang Qian, Head of Med Devices, BSI Asia Pacific  BSI Healthcare (Med Tech), BSI EMEA.

1200 

Q&A

1230

Close & Lunch networking session