TUV USA is proud to host our first annual Medical Device Roadshow.
We are offering 3 classes in a 5 day consecutive training.
• ISO 13485:2016 Internal Auditor Training - 2 days
Roadshow Pricing per person:
Class 1 - ISO 13485:2016 Internal Auditor Training - 2 day - $950.00
Class 2 - Medical Systems Courses Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition Training & Technical Documentation for MDR - 2 day - $1,700.00
Class 3 - MDSAP Implementation & Participating Country Regulatory Processes Class - 1 day - $950.00
Special pricing on combination classes*
Classes 1 & 2 $2,500.00 $150 savings
Classes 1 & 3 $1,800.00 $100 savings
Classes 2 & 3 $2,500.00 $150 savings
All 3 Courses - $3,200.00 $400 savings
*per person - cannot be distributed by group
Medical Devices Roadshow 2018
Choose your Roadshow below
Meet our Trainers
Currently acting as Global regulatory support for medical devices under the name QUADRAS. During his over 25 years of experience in Medical Device regulatory affairs he actively accompanied as member of the various European notified body groups the introduction of the European Medical devices directives as Head of certification for medical devices at RWTÜV. This act Later on he shared his experience under the name QUADRAS as trainer and regulatory affairs expert for international regulations in over 60 countries of the world now introducing again the new european MDR as well as the MDSAP principles.
Indira is subcontract Lead Auditor for TUV USA, Inc. She is a subject matter expert in quality management systems with more than 20 years of experience in auditing Quality Management Systems to ISO13485, ISO 9001, CMDCAS, and the MDD as part of the CE Marking process. Her expertise is in sterile disposable medical devices. Prior to joining TUV USA, Indira worked in the Medical Device Industry in Quality and Regulatory Affairs functions.
Meet our Speakers
Mr. Chen is Director of Medical Products Division. He also serves as Technical Manager, Senior Auditor; Lead Auditor for ISO 9001, ISO 13485, under MDSAP and CMDCAS, CSAP at TUV USA Inc. (Member of TUV NORD Group). His specialties include QMS (ISO 9001, ISO 13485), Technical Expert for active medical devices (MDD 93/42/EEC), ISMS (ISO 27001), GHG (ISO 14064), REACH, QC, FDA, ISO/IEC Guide 65; CMDCAS; MDSAP. He has audited a wide range of industries. He is also trained in Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation (European Union) and other standards and regulations.
He has around 15+ years of work experience in manufacturing, production engineering, quality and regulatory affairs. In his current position in TUV USA Inc.’s office, he leads a team of lead auditors and technical experts in the Medical Product Division, planning for audits, understanding customers’ requirements, reviewing all application for certification/ re-certification/ extension audits, conduct medical and non-medical QMS audits worldwide, perform independent technical review of QMS audit files and performs evaluation of technical documentation for CE mark. He also represents the medical division in Regulatory Body Forum meetings, participates in on-going discussion in conjunction with other CBs and interacts with the Regulatory Authorities and Accreditation Body.
He received his formal education – Masters of Business Administration (MBA) from National Taiwan University, Taiwan; Master of Science (M. Sc. - Bio Medical Instrumentation) from Birla Institute of Technology, India and Bachelors of Physics (with Honors) from St. Xavier’s College, India.