Events

MedTech Workshop on Design an Development of Medical Device as required by EU and FDA / EU Design Dossier

Date: 28 Jul 2010 - 28 Jul 2010

Venue: SIMTech Auditorium, Level 3

Introduction 

This seminar has been specifically designed for participants who are tasked to design and develop products and prepare the Technical File/Design Dossier conforming to the market access requirements of major countries that form the GHTF (Global Harmonisation Task Force) bloc.  Participants will gain a better understanding of the design and development processes to ensure that the Design History File is complete in terms of conformance to the requirements of major world-wide markets. Its correlation to the requirements of Technical File/Design Dossier will be emphasised in accordance with all the required harmonised standards applicable.

Abstract
Design and Development
It is envisaged that to facilitate conformance to the harmonised medical device QMS (Quality Management Systems) regulatory requirements for the major world-wide markets, EU, US FDA and GHTF, design and development processes as part of EN ISO 13485:2003+AC 2007 Quality systems – Medical devices – System requirements for regulatory purposes need to be addressed and complied with. 

Design and Development flow of requirements from planning, inputs, outputs, review, verification and validation will be discussed in detail. Risk Management as used in the Design Input stage and as applied throughout the Product Realisation Stage will be highlighted. A functional understanding of Failure Mode and Effects Analysis (FMEA) will be provided in developing DESIGN and/or PROCESS FMEA to implement FMEA techniques.

EU Design Dossier
Whereas the expression 'Technical File" is for Medical Devices with Classifications I,IIa and IIB, the term "Design Dossier" is applicable to Class III devices. The short talk will include the structure, documentation and all the sections required with reference to MDD/93/42/EEC and Recommendation NB-MED/2.5.1 Technical Documentation. Comparison to the GHTF STED and the ASEAN CSDT (Common Submission Dossier Template) will be highlighted. 
  

About the Speaker
Ms Jocelyn delos Reyes is a Chemical Engineer with 30 years experience in the fields of Quality Assurance and Quality Management Systems specialising on Medical and In-Vitro Diagnostics Devices. She is currently the General Manager of TÜV Rheinland Singapore Pte Ltd. Concurrent to the Office Management positions, Jocelyn delos Reyes has carried out Medical Device Audits for the European Market since 1995 and has since then maintained Authorisations as Notified Body Lead Auditor for TÜV Rhineland Group for Medical Device Directive 93/42/EEC/MDD for non-active devices and ISO 13485: 2003 Lead Auditor for the EU, Japan and Canada markets.

Programme 

12.30pm

Registration

1.00pm

Introduction of Speaker

1.15pm

 

Design & Development Control Guidance
EN ISO 13485 + AC 2007
FDA (Food and Drug Administration)
GHTF (Global Harmonisation Task Force)

3.00pm

Tea Break and Networking

3.30pm

Structure of a Design Dossier

5.30pm

Q&A Session

6.00pm

End of Session

 

Who Should Attend
- Senior management staff, R&D managers, engineers, medtech professionals 
- Industry participants who need to gain the relevant and practical information in fulfilling the regulatory requirements in the design and development of medical device. 
 
Registration Fees
Pre-registration for the workshop is required. To reserve a place, please register online.

Non MedTech Consortium Member : S$321.00 (inclusive of 7% GST)

MedTech Consortium Members are entitled to 2 complimentary seats

SMS Members : $256.80 (inclusive of 7% after 20% discount)  

All cheques and bank drafts must be made payable to "Singapore Institute of Manufacturing Technology', crossed and marked 'A/C payee only'. The workshop title should be written on the back of the cheque.

GST Registration No : M9-0000888-J

Contact Us
For technical enquiries:
Mr Yeo Joo Chuan, Email: jcyeo@SIMTech.a-star.edu.sg; Tel: 6793 8980

For general enquiries:
Alice Koh, Email: kohth@scei.a-star.edu.sg; Tel: 6793 8249