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Hart Biologicals
Quality Statement & Quality Policy

Hart Bio's Quality Statement
To produce safe, innovative, In-Vitro Diagnostic products in partnership with our customers.
To ensure all relevant regulations and standards are adhered to, and an accurate record of regulated activities is maintained.
To ensure product compliance through rigorous in-process and endpoint testing.


Quality Policy
This policy underpins the strategic aims and objectives of the business.

Hart Biologicals Ltd. – “Partners in Haemostasis Testing.”

Hart Biologicals works with their customers through R&D, prototyping validation, and finally contract manufacture of IVD products. Customers may work with us at any stage of this process.

Hart Biologicals also provides an own label range of high-quality products in the areas of coagulation testing and platelet aggregation diagnostics.

Hart Biologicals is fully committed to developing and maintaining a Quality Management System that conforms to the current requirements of 21 CFR 820, IVD Regulation (EU) 2017/746 and BS ISO 13485:2016 where applicable, as well as any changes to these regulations going forward.  This will allow the company to consistently meet the needs and expectations of its customers from order enquiry through to product delivery and service.

Quality is the responsibility of all our employees, with each person in the organisation understanding the role that they play, and of how this ensures that the business continues to be successful within its given field.

Quality Objectives:

  • To maintain compliance to all relevant statutory and regulatory requirements relating to our products and service.
  • To work in conjunction with our customers to manufacture bespoke IVD products.
  • To increase sales by 100% by 2024 through innovation and maximising business opportunities.
  • To form a close partnership with our distributors and wholesalers, educating them on providing the best customer service possible to improve sale prospects.
  • To commit to the continual development and support of all employees, ensuring they can contribute effectively to the success of the company.

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