About Us
Walsh Medical Devices Inc.’s Quality Policy, as part of our overall company policies, is as follows:
Walsh Medical Devices Inc. is dedicated to providing high-quality products and services to ensure the complete satisfaction of our customers.
We recognize that our success is built on strong partnerships — with our customers, employees, regulatory authorities, vendors, the communities in which we operate, and our shareholders. Among these, our customers remain the foremost priority.
Walsh Medical Devices Inc. is committed to meeting or exceeding the expectations of our partners consistently and reliably. We empower all employees with the authority and responsibility to seek continual improvement of the Quality Management System across all aspects of our operations to better serve our stakeholders.
This Quality Policy has been effectively communicated and reinforced throughout the organization via regular training sessions and meetings. This ensures that all employees understand, embrace, and implement the policy within their daily responsibilities.
Walsh Medical Devices Inc. maintains a Quality Management System based on ISO 13485:2016 and applies risk-based thinking throughout all processes to ensure product safety, performance, and regulatory compliance.
The organization is committed to compliance with applicable regulatory requirements, including:
The Canadian Medical Device Regulations (CMDR), SOR/98-282
The FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, as incorporated by reference to ISO 13485:2016
The European Union Medical Device Regulation (EU MDR 2017/745), including requirements applicable to CE
The United Kingdom Medical Devices Regulations 2002 (UK MDR 2002), as amended, including applicable requirements for UKCA marking and conformity assessment under the post-Brexit medical device regulatory framework
Walsh Medical Devices Inc. is committed to upholding the highest standards of safety, performance, and quality in all markets in which it support this commitment, Walsh Medical Devices Inc. has established the following strategic business goals:
Market Leadership – To be the leading supplier of lacrimal intubation products in North America and a trusted provider in the European Union and other global markets.
Lean Manufacturing – To optimize operations by controlling inventories, reducing manufacturing cycle times, minimizing waste, and improving yields while ensuring timely of customer orders.
Product Development – To design and deliver innovative, compliant, and market-relevant products that meet or exceed customer expectations in all regions we serve, including those governed by EU MDR requirements.
Customer Engagement – To enhance our understanding of customer needs and product performance through proactive post-market surveillance and post-market feedback activities, including customer surveys, trade show participation, complaint trending, and regular feedback collection, in alignment with ISO 13485:2016 and applicable regulatory requirements under CMDR, FDA QMSR, and EU MDR.
These goals are pursued through the active engagement and commitment of both employees and management to this policy, which serves as the framework for setting, reviewing, and achieving quality objectives.
Walsh Medical Devices Inc. ensures that all necessary resources and training are made available to meet both current and future regulatory, market, and customer demands. The Quality Policy and Quality Management System are reviewed periodically during management review meetings to evaluate their continuing suitability, adequacy, and effectiveness, and are revised as necessary to ensure ongoing compliance with ISO 13485:2016, the FDA Quality Management System Regulation (QMSR), CMDR, and EU MDR, and to drive continual improvement of the Quality Management System.