Stakeholders

Stakeholder Engagement Report

The company's business activities and services interact mutually with stakeholders. Their degree of concern regarding key issues directly impacts the formulation of our corporate strategies and development goals. Therefore, LAGIS places great emphasis on and actively implements effective stakeholder communication. Based on the five principles of the AA1000 Stakeholder Engagement Standard (SES)—Dependency, Responsibility, Tension, Influence, and Diverse Perspectives—the company systematically reviews its operational activities and refers to identification results within the biotech/medical device industry. Consequently, we have identified five primary stakeholder groups: Customers, Employees, Government Agencies, Shareholders, and Suppliers.

Tailoring communication methods to each stakeholder group based on their material topics and engagement objectives, the company reports the results of stakeholder interactions to the Chairman on an annual basis.

Significance of Stakeholders, Material Topics, Communication Channels, Frequency, and Communication Results
Stakeholders	Significance to the Company	Material Topics	Communication Channels	Frequency	Results & Responses
Customers	Customers are essential partners in our business growth. Providing satisfactory, reliable, and safe products and services is our commitment, as we continuously innovate to enhance mutual competitiveness.	Product Responsibility & Safety Product Quality & Recall Mechanism Affordability & Pricing Product Innovation & R&D Financial Performance Business Integrity & Regulatory Compliance	Customer Satisfaction Survey	Once / year	Conducted customer satisfaction surveys once annually. Local site visits: At least 1-2 times per year for clients in Japan, Korea, and China; at least once every 2 years for other regions based on specific regional needs. Online Meetings: At least 1-2 virtual meetings per year with each client for specific topic discussions. Client Visits: Hosted medical delegation visits (e.g., doctors and nursing teams from Japan, Korea, Thailand, Singapore, etc.). Participated in 1-2 major international exhibitions annually (e.g., Medica in Germany, WHX Dubai, WHX Miami in the US, Hospitalar in Brazil) according to strategic market focus. Email Communication: Prompt response to customer needs and regular follow-ups on account statuses.
			Local Business Visits	At least once every 1-2 years (depending on region)
			Online Meetings	Ad hoc, at least 1-2 times per year
			Client Exchange Visits	At least once per year for Japan & Korea
			Exhibitions	Annual participation in regional exhibitions
			Email Communication	Ad hoc / Immediate response
Employees	Employees are the company's vital assets. We actively attract, cultivate, and retain talent while creating a respectful and safe work environment, empowering every employee to fulfill their career potential.	Product Responsibility & Safety Business Integrity & Regulatory Compliance Product Quality & Recall Mechanism Energy & Greenhouse Gas Management Waste Management Financial Performance	Internal Announcements	Ad hoc	Internal Announcements: 25 notices published in the year. Labor-Management Meetings: 4 meetings held annually. Factory Management Meetings: 45 meetings held annually. Department Head Meetings: 27 meetings held annually. Executive Management Meetings: 12 meetings held annually. Employee Suggestion Box: Continuously open.
			Labor-Management Meetings	Quarterly
			Factory Management Meetings	Weekly
			Department Head Meetings	Weekly
			Executive Management Meetings	Monthly
			Employee Suggestion Box	Ad hoc / Continuous
Government Agencies	In addition to observing governmental regulations and proactively aligning with policy enforcement, we build trust, support, and cooperation through transparent two-way communication to stay abreast of regulatory trends and ensure compliant operations.	Product Responsibility & Safety Business Integrity & Regulatory Compliance Product Quality & Recall Mechanism Waste Management Energy & Greenhouse Gas Management	Official Correspondence	Ad hoc	Official correspondence: Average of 26 letters/month; 56 letters/year specifically with Taiwan Ministry of Health and Welfare (MOHW). Regulatory Information Sessions: 7 sessions/year. Seminars/Symposia: 1 event/year. Material Information Filings on MOPS: 36 disclosures/year. Taiwan Medical Device Quality Management Application Platform: 2 submissions/year. Taiwan Medical Device Registration E-Submission System: 10 submissions/year. Taiwan National Health Insurance Information System: 2 submissions/year. Taiwan Medical Device Unique Device Identification (UDI) Platform: 2 submissions/year. US FDA User Fee Website: 1 submission/year. US FDA CDRH Customer Collaboration Portal: 3 submissions/year. US FDA Global Unique Device Identification Database (GUDID): 1 submission/year.
			Regulatory Information Sessions	Ad hoc
			Seminars/Symposia	Ad hoc
			Material Information Disclosures	Ad hoc
			On-site QMS Audit (Taiwan FDA)	Every 3 years
			Medical Device QMS Application Platform (TFDA)	Ad hoc
			Medical Device Registration E-Submission System (TFDA)	Ad hoc
			Medical Device Contract Manufacturing Online Application (TFDA)	Ad hoc
			Post-market Quality Management System for Drugs, Medical Devices, Food & Cosmetics (TFDA)	Immediate
			NHI Information System (Taiwan NHIA)	Ad hoc
			Medical Device UDI Management Platform (TFDA)	Ad hoc
			MHRA MORE Vigilance System (UK MHRA)	Immediate
			FDA User Fee Website (US FDA)	Ad hoc
			FDA CDRH Customer Collaboration Portal (US FDA)	Ad hoc
			FDA Electronic Submissions Gateway (US FDA) FDA GUDID (US FDA)	Ad hoc
Shareholders	Shareholders and investors are vital pillars of corporate growth and the driving force behind sustainable value creation. Transparent disclosures of management strategies and financial policies ensure sustained shareholder confidence.	Product Responsibility & Safety Product Quality & Recall Mechanism Financial Performance Talent Attraction & Retention Product Innovation & R&D Risk & Crisis Management Business Integrity & Regulatory Compliance	Annual General Meeting (AGM)	Annually	Published quarterly financial reports: 4 times/year. Held Annual General Shareholders' Meeting: 1 time/year. Disclosed material news via MOPS: 36 filings/year.
			Annual Financial Report	Annually
			Financial Statements	Quarterly
			Market Observation Post System (MOPS)	Immediate
			Investor Relations Contact Window	Immediate
Suppliers	Suppliers are essential strategic partners. We build trustworthy, long-term relationships through fair and transparent collaboration.	Product Responsibility & Safety Business Integrity & Regulatory Compliance Product Quality & Recall Mechanism Information Security & Data Protection Supply Chain Management	Quotations	Immediate	Supplier Audits: Conducted on-site verification and guidance at least once a year for suppliers involved in sterilization, laser welding, silicone, rubber, plastic manufacturing, and high-risk categories. On-site Checklists: Applied annual on-site audit checklists for high-risk and key component suppliers. Supplier Scorecards: Evaluated incoming batch quality monthly, computing annual performance averages at year-end.
			Purchase Orders	Immediate
			Quality Agreements	Immediate
			Contracts	Immediate
			Audit Visits	Ad hoc
			On-site Checklists	Ad hoc
			Supplier Scorecards	Regularly
			Quality Corrective Requests (QCR)	Immediate
			Outsourcing Orders	Immediate
			Supplier Profiles / New Vendor Evaluation Forms	Immediate