Events

Seminar on Updates of US and European Regulatory Requirements for the MedTech Industry

Date: 19 Mar 2013 - 19 Mar 2013

Venue: SIMTech Auditorium, Tower Block, level 3

Introduction

This half-day seminar presents participants the opportunity to understand regulatory requirements for launching MedTech devices to the US and Europe, the largest markets in the world.  The presenter will share the latest changes and update of FDA Guidance, Compliance, & Regulatory Information.  Speakers will also be delivering updates on European Regulatory System and Clinical Evaluation & Market Surveillance.

08.30am

Registration

09.00am

Introduction

Mr John Lim, Senior Consultant, PE COI
- SIMTech X-Ray Sterilization CIP Programme

09.15am

Accessing the US MedTech Markets - Regulatory Requirement and Updates

Mr Paul Tan, Senior Principal Consultant, TUV SUD PSB Singapore
Topics include:

Regulatory requirements
US market access
Definition
Registration
Risk classification
PMA (Post Market Approval)
QMR (Quality Management Regulation)
QSIT (Quality System Inspection Technique)

10.00am

Update on European Regulatory System - Revision of Medical Devices Directive (MDD) and the In Vitro Diagnostic Device Directive (VDD)

Ms Jocelyn Delos Reyes, General Manager, TUV Rheinland
Topics include:
Revision of MDD and IVDD
Overview on major changes in legislation
Borderlines to Medicinal products, Food and Neutraceuticals
Implementation into the Regulatory System
Responsibilities of Economic Operators
Registration requirements (UDI, Eudamed)
Timelines
Consequences for your Business in Europe
To Dos for manufacturers
Documentation requirements

10.45am

Tea break and Networking

11.10am

Clinical Evaluation and Market Surveillance

Dr Michael Rinck, Managing Director, MT Promedt Consulting GmbH
Topics include:
Clinical Evaluation and Market Surveillance
Clinical evaluation - requirements and application
Post Market Surveillance
Risk management approach to clinical evaluation
Future documentation requirements

12.50pm

Q&A

End of Seminar

About the Speakers

Mr Paul Tan  is the Senior Principal Consultant specialising in Medical Devices certification and strategic business development of TUV SUD PSB Pte Ltd. He is an authorised active medical device auditor and also a Lead Auditor in the IECEE CB Scheme. He is the Chairman of the Singapore German Chambers Healthcare Committee and has over 25 years of testing experience & product certification.

Ms Jocelyn Delos Reyesis is the General Manager of TÜV Rheinland Singapore Pte Ltd and a Notified Body Lead Auditor for TÜV Rheinland Group. Jocelyn is a Chemical Engineer and has 16 years experience in the field of CE Marking for non-active Medical Devices.  

Dr Michael Rinck is the Managing Director of MT Promedt Consulting GmbH and has especially flown in from Germany to deliver the topic on Quality Assurance and Regulatory Affairs Projects on Medical Devices and IVD Products, Clinical Evaluations  & as an European Authorized Representative for international companies.

Dr Rinck is a regulatory specialist with strong scientific background in microbiology possessing a Diploma and a Ph.D. in Microbiology from Technical University Berlin and a License in Pharmacy. He has conducted research in antimicrobial coating, biomaterials and sterilization technologies and developed and implemented these into routine manufacturing processes.

He has many years of international experience in Europe and the USA in regulatory processes for certification of innovative medical devices including new biomaterials, combination product and devices with animal tissue. Product experiences are available in the areas of orthopaedic implants, absorbable biomaterials, extracorporeal systems and immuno-apheresis technologies, cardiovascular products, drug eluting stents, blood collection systems and IVD products as well as sterile parenteral solutions for dialysis and infusion.

Special areas of interest are toxicological evaluations of biomaterials and Extractables/Leachables, process validation such as sterilization, aseptic filling and virus removal and Clinical evaluations.

Who Should Attend 
This seminar is designed for a multidisciplinary audience of Directors, Managers, Department Heads, Supervisors, Senior Specialist from:

Quality Control and Assurance 

Quality Management 

Quality by Design 

Compliance 

Validation 

Manufacturing 

Purchasing 

Regulatory Affairs 

Process Development 

Process Engineering 

Production 

R&D

Registration

Registration for this seminar is free of charge and seats are available on first-come, first-served basis. To reserve a place,please register online.

Contact Us

For more details, please contact Mr John Lim Kee Yong, Senior Consultant, PE COI, Tel: 6793 8248, Email: kylim@SIMTech.a-star.edu.sg