Quality Policy

As part of a dedication to excellence Prosum Medical Ltd. is committed to the consistent supply of high-quality medical products, to innovative designs, which provide outstanding value to the users. 

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The company shall comply with the requirements of EN ISO 13485:2016, the European Council Directive 93/42/EEC of June 1993 concerning Medical Devices and the subsequent revisions described in Council Directive 2007/47/EC, UK Medical Device Regulation 2002, the applicable (Article 120) requirements of European Council Medical Device Regulation EU/2017/745 & FDA Title 21 CFR part 820 in order to establish, maintain and continually improve the effectiveness of the Quality Management System Management will strive to attain and maintain the highest possible standards of quality and service in order to meet or exceed customer expectations. It is the company policy to: 

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• Keep & maintain records of the quality management system in accordance with current required standards, regulations and directives. 

• Ensure those involved are trained, and conversant in their role within the quality management system, so that the company consistently supplies quality products and good customer service. 

• Develop or acquire products which are effective, safe & reliable. 

• Strive for continual improvement in performance as detailed in the company’s Quality Objectives 

• Prosum medical devices are manufactured to the state of the art and are engineered to meet all internationally recognised standards appropriate to their intended design & use.  

• Patient safety considerations are central to Prosum’s mission and Prosum is committed to operating a system of clinical evaluation that demonstrates the safety and effectiveness of Prosum medical devices.  

• Operate a robust system of post market surveillance which complies with all regulatory and reporting requirements.