Medical Devices Directives (93/42/EEC) and Technical File Preparation Workshop

The 2 day workshop is to familiarize delegates with the requirements of Directive 93/42/EEC as amended by Directive 2007/47/EEC and to allow manufacturers of medical devices to ensure continued compliance. This workshop is also designed to familiarize quality and regulatory professionals, engineers, supervisors and management with the technical documentation requirements of the Medical Device Directive 93/42/EEC including the 2007/47 amendment.

Topics Covered:

• European Union (EU) Regulation Framework
• What is CE Marking
• MDD 93/42/EEC and latest updates
• Technical documents compilation and essential requirements checklist
• Case Studies
• Workshops  

Who Should Attend:

• Managers, engineers, designers and those who are involved in medical devices
• New regulatory affairs/ quality assurance staff needing training on 93/42/EEC
• Personnel who need to prepare technical documentation to meet requirements of Medical Device Directives 93/42/EEC including the 2007/47 amendment

The Trainers:

Ms Lee Lai Mei
Business Development Manager & Lead Auditor, SGS International Certification Services Singapore Pte Ltd

Ms Lee Lai Mei has over 20 years of auditing & training experience and is a qualified lead auditor for ISO 13485 Medical Devices QMS and Medical Device Directive 93/42/EEC. In addition, she is an approved auditor to conduct audits under Canadian Medical Devices Conformity Assessment System (CMDCAS) and Japanese Pharmaceutical Affairs Law (JPAL). 

Ms Tan Hwee Ee
Founder & Principal Consultant, DH RegSys Pte Ltd

Ms Tan Hwee Ee is the founder of DH RegSys Pte Ltd where she is also the Principal Consultant. Hwee Ee has over 20 years of experience in the medical industry principally in medical device organisations as a consultant, engineer and senior manager. She provides consulting, training services and product solutions to the medical device and related industries for regulatory bodies such as Singapore HSA, Australia TGA, US FDA, EU and etc. She is also a member of Working Group 4 (WG4) of the AHWP (Asian Harmonization Working Party) and is a Certified Biomedical Auditor with ASQ.

For more information or registration for the workshop:

Contact Yong Shan from Singapore Manufacturing Federation directly at yongshan@smfederation.org.sg or call +65 68263057.