Quality Policy

Anax Associates (Pvt) Ltd manufactures single-use sterile surgical drapes, surgical gowns and face masks under the MedPro™ brand for hospitals and healthcare providers. Our purpose is to protect patients and healthcare professionals by maintaining a sterile field and preventing contamination during medical procedures. The safety and performance of every device we place on the market is the foundation of our business.

Top management of Anax Associates is committed to:

• Providing safety and Performance Requirements, the harmonized product standards EN 13795-1 and EN 14683, the DRAP Medical Devices Rules 2017, and the requirements of the markets in medical devices that are safe, perform as intended, and consistently meet customer requirements and applicable statutory and regulatory requirements – including ISO 13485:2016, Regulation (EU) 2017/745 (MDR) and its General Swhich our devices are sold.
• Maintaining the sterility assurance of our products through validated ETO sterilization, controlled manufacturing environments, and rigorous batch release – recognizing that our devices protect people at their most vulnerable.
• Maintaining an effective quality management system based on ISO 13485:2016 and compliant with MDR Annex IX, and sustaining its suitability, adequacy and effectiveness through management reviews, internal audits, post-market surveillance, vigilance, and corrective and preventive action.
• Applying risk management throughout the product life cycle – from design and material selection through production, sterilization, distribution and post-market feedback – in accordance with ISO 14971.
• Providing the resources, infrastructure, training and competent personnel – including a Person Responsible for Regulatory Compliance – needed to achieve product conformity and regulatory compliance.
• Working with qualified suppliers and listening to our customers, so that feedback, complaints and market experience continually drive improvement of our products and processes.

This policy provides the framework for establishing and reviewing measurable quality objectives, which are set at relevant functions and levels of the organization and monitored in management review.

The Quality Policy is communicated to all employees through induction and refresher training and prominent display at our facility, so that it is understood and applied at every level of the organization. It is reviewed in management review for continuing suitability and revised whenever the context of the organization or applicable requirements change.