Hurdles sample collection kit product suite cover a wide range of diagnostic and screening tests. Blood, stool, urine, swabs, in various combinations, enable patients’ samples to be collected safely at home and sent to and certified laboratory for testing, analysis and data provision. Kits are manufactured in a state of the art manufacturing facility meeting healthcare, data security, environmental and sustainability standards. This best practice being the foundation of the Hurdle supply chain.

Compliance with International Standards

• ISO13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
• ISO 14001:2015 – Environmental management systems
• ISO45001: 2018 – Occupational health and safety management systems — Requirements with guidance for use
• ISO15189:2022 – Medical laboratories — Requirements for quality and competence
• CLIA – Clinical Laboratory Improvement Amendments (CLIA)

Usability & Safety

These sample collection kits are indicated as both professional or lay use (at-home) test kits. Each has gone through structured usability testing against harmonised requirement IEC 62366-1 to guarantee through the design that the user can complete the sample collection process in a simple and safe manner. Hurdle’s kits facilitate samples to be registered and easily returned to the laboratory for testing using Royal Mail Tracked 24 postal service. 

Sample Transportation and Laboratory Compliance

All returning samples are transported only for the purpose of diagnosis or investigation to a suitable laboratory who will undertake the required testing under validated test methods. The transportation of samples is carried out in compliance with the dangerous goods classification B against required regulation, namely UN3373. Each laboratory within the Hurdle network of approved partners must be ISO 15189 certified. ISO15189 is a general standard applicable to all medical laboratories, regardless of their speciality, focus area or geographical location.

While it provides a solid foundation for quality management in a medical laboratory, some specialised laboratories may require additional accreditation or certification specific to their field to address unique technical or regulatory requirements. One example of  an additional regulatory requirement would be CLIA (Clinical Laboratory Improvement Amendment) certification issued by the FDA for medical laboratories. It’s also important to note that getting ISO 15189 accredited isn’t mandatory in territories like the US, but it is in many other countries worldwide. Regardless of where Hurdle customers are based, we will ensure our customers use laboratories that hold current ISO 15189 certification.

Data Security and Privacy

Results are processed by the laboratory and returned directly to the healthcare organisation for further communication with the end user. To ensure data security, Hurdle has accredited its organisation against the requirements of ISO/IEC 27001:2022 – Information security, cybersecurity and privacy protection — Information security management systems – Requirements. SOC2 Type 1 Certification and independent Cyber Security certifications. Hurdle also complies with Global Data Protection Regulations and a data controller and comply in full with the Health Insurance Portability and Accountability Act (HIPAA)

Regulatory Marking and Market Access

Hurdle sample collection kits are both CE and UKCA-marked against the requirements of the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. Each kit type can be branded to meet a customer requirement or request and where necessary, can be translated to the region of sale. Hurdle maintains representation and market access within the United Kingdom, Europe, United States, Middle East and North Africa and Australia and has access to an extensive laboratory network across each region in which each kit has met all regulatory requirements to be approved for commercial use.

NHS Clinical Safety standards

Hurdle currently holds processes to govern its clinical risk management in line with NHS Clinical Safety standards which are designed to help manufacturers of health IT software evidence the clinical safety of their products. The organisation will also offer compliance to DCB1060 standard designed to help health and care organisations assure the clinical safety of their health IT software when interacting with Hurdle active interfaces. 

As part of Hurdle’s commitment to innovation, ongoing research and development is in progress to develop artificial intelligence into its technical and data management systems for further compliance to ISO42001:2023 which will allow the organisation to offer a platform with further functionality for its customers. 

Hurdles commitment to quality,  compliance and excellence throughout its design, manufacture and deployment of its healthcare related products is the cornerstone of its mission and commitment to its customers. This mission is designed to not only meet, but to exceed each individual’s customer expectation on an ongoing basis.