Hart Biologicals Ltd. is a company specializing in development and manufacturing of IVD products for Haemostasis Testing as a contract manufacturer as well as a legal manufacturer.
Hart Biologicals is dedicated to providing health care professionals and patients with uncompromised quality
Our mission is to provide the highest level of quality and customer satisfaction in all aspects of IVD devices development, manufacturing, marketing, sales, and technical support through continuous improvement with our people, processes, and facilities.
Hart Biologicals strives for continuous improvement: “We care about our customers” and we are your “Partners in Haemostasis Testing’’
Hart Biologicals Ltd. will ensure that all products and activities comply with all applicable safety, performance, regulatory and customer requirements. Quality must be designed and built into the product from the outset. To achieve this, we are committed to establishing a Quality Management System which helps to control any risk associated with Hart Biologicals Ltd. activities and processes, ensuring they remain effective and provide a framework to improve the company’s performance.
• Hart Biologicals Ltd. Management Team and all its employees are committed to the quality of our products, development activities, and documented Quality Objectives. All our employees are aware, that Quality is responsibility of everyone in the company and how crucial role every employee play in ensuring the safety of our products.
• Hart Biologicals Ltd. will maintain a Quality Management System to meet the current requirements of EN ISO 13485:2016 and 21 CFR Part 820 and any other worldwide regulatory and standard requirements that the company’s business strategy requires.
• The Management Team will review regularly (at least annually during management review) the performance, effectiveness, and suitability of the Quality Management System and the achievement of the Quality Objectives together with the Quality Policy and company Quality Manual and make sure that all of it is always translated and understood by all employees.
