You are invited to this free webinar!
Overview on ISO 13485:2016 Medical devices — Quality Management Systems — Requirements for Regulatory Purposes
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Learn about the requirements of ISO 13485:2016 that are applicable to organizations regardless of size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
Webinar Flow
Friday, 22 April 2022
1:45 pm - 2:00 pm
Registration
Speakers and Participants
2:00 pm - 2:10 pm
Webinar Overview and House Rules
Webinar Moderator
2:10 pm - 2:20 pm
Welcome Remarks
Engr. Tristan Arwen Loveres
Managing Director
TÜV Rheinland Philippines
2:20 pm - 3:20 pm
Overview on ISO 13485:2016 Medical devices — Quality Management Systems — Requirements for Regulatory Purposes
Ms. Jocelyn Reyes
Senior Lead Auditor, Medical Products
TÜV Rheinland Singapore Pte. Ltd.
3:20 pm - 3:50 pm
Q&A Session
Speakers and Participants
3:50 pm - 4:00 pm
Closing
Webinar Moderator
Webinar Details
- Date: 22 April 2022
- Time: 2:00 pm - 4:00 pm
- Language: English
- Registration Fee: Free
Target Participants
- Medical Device Manufacturers
General Reminders
- Participants will not receive any form of certificate for this free webinar.
- Presentations will not be shared with the participants after the webinar.
Terms and Conditions
- TÜV Rheinland reserves the right to alter or cancel any seminar at any time. In the event of cancellation on our side, participants will be duly notified.
- By signing up, you allow us to use and process your personal information for any purpose related to this seminar. Your data will be kept as long as needed for communication or organization reasons.
- All intellectual property rights in all training material available, including the design, graphics and text of all printed materials, are owned by TÜV Rheinland. No training material and/or content of the workshop may be copied, reproduced, uploaded, posted, displayed or linked to in any way, in whole or in part, without our prior permission from TÜV Rheinland. Any such use is strictly prohibited and will constitute an infringement of intellectual property rights.
Registration
Participation in this webinar does not incur any participation fees for you. In return for participation in our webinar, we only ask for your contact details and your consent to inform you regularly by e-mail about TÜV Rheinland products and news in the future. The fields marked with * are required for a region-specific contact person to coordinate discussions. This enables us to process your inquiries quickly and competently.
If you have any questions or need further information, please do not hesitate to contact us in advance.
Fill out the form below to reserve your place! See you at the webinar.
About the Organizer
TÜV Rheinland stands for safety and quality in virtually all areas of business and life. Founded almost 150 years ago, the company is one of the world’s leading testing service providers. TÜV Rheinland’s highly qualified experts test technical systems and products around the world, support innovations in technology and business, train people in numerous professions and certify management systems according to international standards. In doing so, the independent experts generate trust in products as well as processes across global value-adding chains and the flow of commodities.
Connect with us!
Back to top
