Program

Invited Speakers

 

* Sorted by last name



Yulianti Darmanto
Manager
Hewlett Packard Enterprise, Indonesia

Yulianti Darmanto (Dessy Lee) is working with Hewlett Packard Enterprise, Taiwan. She has an in-depth knowledge in the field of Product Safety (design, testing, certification-application) and country specific regulatory certifications. She has worked with some of the leading International IT manufacturers and various Taiwan local Suppliers including her participation to multiple IT associations and local association. Dessy started her career as Safety Engineer 13 years ago at MSI (local Taiwan company) and now she heads the Asia Pacific & Japan Region at HPE. She takes care of the Product Compliance Regulatory Affairs (EMI/EMC, Safety, telecom incl. wireless, Environmental such as energy efficiency, material, packaging until WEEE Takeback, security regulation) for whole Asia Pacific Japan countries & participate in safety TAC/Technical Advisory Committee of HPE. She will give her insight of product regulatory compliance how Product Compliance move and become more complex and what is relationship with Trade with Product Compliance.

Speech Info

APJ Product Compliance Movement

Hasnaa FATEHI
Founder
QARALOGIC Consulting Inc., Taiwan

After a thriving career in different Regulatory and Quality roles in start-ups and Fortune 500 companies, Hasnaa started her own business, QARALOGIC Consulting Inc., to help companies bring their medical innovation to patients in need.

Hasnaa is a RAC (Devices) holder, a certified (BSI) 13485:2016 Lead Auditor and a qualified PRRC (person responsible for regulatory compliance) for the EU-MDR/IVDR transition. In addition to the EU regulations, Hasnaa supports companies with low to medium risk marketing applications in the US, Australia and Canada.

Hasnaa moved to Taipei, Taiwan in January 2020, where she opened a branch office of her boutique consultancy business and has been a very active of the local MedTech/Digital Health community.

Speech Info

ICT for Health - Adding Business Value through Regulatory Compliance

Taiwan's ICT industry is undeniably strong. In the past years, and exacerbated by the Covid-19 pandemic, new trends started emerging whereby more Taiwanese ICT companies are developing medical devices or related healthcare services. At the same time, several new government policies such as the "5+2 Innovative Industries" and the "6 Core Strategic Industries" plans place Bio-medicine, Smart Healthcare and Digital Transformation have at their heart. While Taiwan has every reason to succeed in the shift from ICT to Healthcare, this move is not a straightforward one. In reality, most ICT manufacturers are not acquainted with the healthcare industry idiosyncrasies, not to mention Taiwan's dependence on export. This makes it even more crucial to manufacture and sell devices designed with global regulators and users in mind. In this presentation, practical insights on the medical device industry will be shared with an emphasis on key regulatory requirements and organizational culture as indispensable strategies to success in the MedTech industry.

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Chee Beng Wai
Technical Specialist
CSA Group, Singapore

CheeBeng (or simply CB) is a Technical Specialist of CSA group for the Hitech business unit. He started his career as a power supply design specialist in 2003 for Panasonic Electronic Devices in designing and evaluating power supply for various information technology product ranging from DVD players, LED/PDP TV, projectors and gaming machines. One of his responsibility also included product safety and EMC design for PSU.

Speech Info

Systematic Approach in Power Supply Safety Design

Power conversion has been the key to every product design, especially in modern data servers and networking products. Most electrical and power safety is considered internally at power supply or by respective installation evaluated as necessary. Developing and implementing a comprehensive and yet systematic approach to assess the applicable hazards is required, considering flexibility in the design of safeguard while also influencing a safer product. This keynote presentation will provide a high-level overview of the following three key areas:
1. Specifying hazards need to address (digital or analog)
2. Identifying critical limits
3. Designing of safeguards and applicable testings for adequate safeguards

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Jimmy Deng
Freelance Consultant, Taiwan

With more than 16 years working experience in multiple certification bodies and Medical device manufacturer, Jimmy now starting his career life as freelance consultant. He not only has comprehensive knowledge in global medical devices regulations and safety standards, and also having in-depth practical experience for Quality Management Ssystem like QSR 820, ISO13485, MDSAP as well as market registration and approval activities like MDR and 510K submissions. Meanwhile he is also technical expert in ISO17025 Lab accreditation and now is a registered ILAC (TAF) auditor in medical devices and Laboratory products.

Speech Info

A Brief Overview of Regulatory Considerations for Software as Medical Device (SaMD)


Martin Soderberg
TCO Development, Taiwan

I have more than 20 years’ experience from working with sustainability challenges in the IT-industry through the global sustainability certification TCO Certified. In my current position as Industry Relations Manager I help guide IT-industry stakeholders to understand the criteria and process to achieve TCO Certified for their products. I moved from Sweden to Taiwan in 2005 to open up our representative office in Taipei. In addition to my work with TCO Certified I am also a board member of the Swedish Chamber of Commerce in Taipei since 2016.

Speech Info

Who Can You Trust? – Guidance in the Sustainability Claims Jungle

Professional purchasers that want to take sustainability seriously face a dire task when choosing IT-equipment. Retailers and manufacturers like to claim that their products are sustainable and that they are doing the right thing but the claims are often exaggerated and unproven. Finding your way through this jungle of claims can be time consuming and difficult task. How can you avoid the traps and stay on track to reach sustainability? In this presentation I want to share some of the experiences we gathered from working with professional purchasers and other stakeholders as we strive towards a future with sustainable life cycles for electronics.

Adam Garner
Director
CSA Group

Adam Garner is a member of CSA Group’s Industrial Leadership Team and has worked in the Hazardous Locations TIC industry for over 18 years.
Adam joined SIRA Certification Service in 2003, whereby he worked in a number of management roles including business development, ATEX & IECEx certification advisory services, ‘Ex’ training & competence schemes and ATEX 137 compliance. With the acquisition of SIRA by CSA Group in 2009, Adam continued into leadership roles and currently holds responsibility for CSA’s Commercial activities in EMEA. Adam is actively involved in CSA Group’s offering for the UK’s Conformity Assessment mark (UKCA) working with customers globally on their UK market entry needs.

Speech Info

Introduction to the Regulatory Framework for Ex Safety in Post-Brexit UK and Latest ATEX Status

The compliance landscape across Europe and the UK has changed. As such, this presentation aims to

  • Explain the changes that have occurred since the UK left the EU (Brexit)
  • Provide details of the current status of the ATEX Directive

Richard You
Medical Team Lead
CSA Group, China

Graduated from Zhejiang University with Master degree, Richard has more than 15 years working experience in testing and certification of medical equipment. Richard joined CSA Group in 2015 and is acting as medical team lead of CSA Group in China, and he is responsible for safety and EMC testing and certification of medical product.

Speech Info

Updates to the International Medical Robotics Standards

The speech will focus on introducing international standards which is applicable to medical devices and medical robotics, with an interpretation on the definition of medical robotics, the major risks related to it, and the testing requirements for main robot types.

Giggle Pe
Certifier
CSA Battery Unit

Giggle Pei received her bachelor degree from Soochow University in 2005, She joined CSA in 2018 with over 8 years’ work experience in battery certification work, Giggle is now working as certifier for CSA Group specializing in battery and energy storage systems. She has extensive knowledge and project experience in this field, and acquitted with the related North America Standards, IEC standards and global market requirements of battery products.

Speech Info

Overview of UL 9540A

The speech will focus on introducing ANSI/CAN/UL9540A:2019, Test Method for Evaluating Thermal Runaway Fire Propagation in Battery Energy Storage Systems, and related test report introduction.