ISO 13485 Standards for Success in the Medical Device Business

In today’s rapidly growing and highly competitive medical device industry, product safety, quality, and reliability are essential elements that organizations cannot overlook. ISO 13485 serves as a globally recognized quality management standard that ensures manufacturers, importers, and distributors of medical devices operate in full compliance with strict safety and regulatory requirements.

This online seminar aims to provide a clear understanding of ISO 13485, how organizations can prepare for implementation, and the business advantages it brings—ranging from improved customer confidence and expanded international market opportunities to elevating operations to a truly global standard.

Objective

This online seminar aims to equip participants with up to date knowledge and insights on ISO 13485, the Medical Device Regulation (MDR), as well as the latest updates in medical device laws and regulatory requirements. The session is designed to help attendees understand key changes and apply this information to enhance their quality management systems and ensure compliance with international standards.

Agenda

1. Introduction, review, and update of ISO 13485 requirements
2. Understanding EN ISO 13485
3. Who needs MDR certification?
4. Updates on Medical Device Act and regulations
5. Benefits of ISO 13485
6. SGS service offerings

Target Audience

This webinar is suitable for entrepreneurs in the manufacturing sector, importers, exporters, and interested individuals.

Please register with your business email address as this is a pre-approved event.