The Quality Assurance department at Hart Biologicals covers a wide range of activities and is integral to the achievement of high standards and customer expectation. 

The QA department is made up of five members, Jennifer Feasby, Jenny Leach, Jasmine Pattison, Kelly Ward and Matthew Napper; all contributing to maintaining systems which allow the company to manufacture its products consistently. 

Jennifer Feasby, Quality Manager said: “Regulatory affairs are at the heart of everything we do as a company and without Quality Assurance, the product would not be able to be sold. 

“Developing customer relationships and covering the many varied standards and regulations allows us to successfully trade within the UK and to a variety of countries worldwide.” 

QA updates the extensive number of manufacturing and quality instructions needed to ensure all employees understand how to make and test each product to exact consistent specifications. 

By ensuring all systems are compliant with ISO 13485:2016, the QA department is giving our customers the reassurance they want that the products are made effective and safe for their patients.  

Jenny Leach, Regulatory Affairs said: “Our job involves customer interaction and helping with international product registrations – there is always satisfaction in completing this process and helping customers achieve their goals.” 

The regulatory landscape is always changing and one current, significant change, is the move to the IVD regulation (2017/746); replacing the IVD Directive (98/79/EC) which is the current in vitro device directive in the EU. 

The introduction of the new EU regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) in May 2017, marked the start of a 3 and 5-year transition period, which all manufacturers in this industry must navigate. 

The new classification rules mean that certain devices will be reclassified into high risk categories. This will ensure a stronger focus on clinical evidence for higher risk products and increased traceability of devices and incidents. 

Hart Biologicals is working to ensure a smooth transition to the new regulations and the hard work of the Quality Assurance department will mean that all customers will see little to no disruption in their supply.