Compliance & Regulatory Information

1 Regulatory Status

1.1 Medical Device Registration

HaemoSync is a registered medical device in the United Kingdom.

1.2 Manufacturer

2 UKCA Marking

UK Conformity Assessed

HaemoSync bears the UKCA (UK Conformity Assessed) marking, indicating conformity with the applicable requirements of UK legislation.

2.1 Declaration of Conformity

We declare under our sole responsibility that HaemoSync conforms to the relevant provisions of the UK Medical Devices Regulations 2002.

2.2 Conformity Assessment

As a Class I medical device, HaemoSync has undergone self-certification conformity assessment in accordance with Annex VII of Directive 93/42/EEC as transposed into UK law.

3 Intended Purpose

3.1 Intended Use Statement

HaemoSync is a clinical decision support software intended to:

3.2 Intended Users

• Qualified healthcare professionals (doctors, nurses, clinical practitioners)
• Registered clinics and medical practices
• Laboratories and diagnostic service providers

3.3 Intended Patient Population

• Adult patients undergoing routine or diagnostic blood testing
• Patients referred by healthcare professionals for blood panel analysis

3.4 Intended Use Environment

• Clinical settings (GP surgeries, private clinics, hospitals)
• Laboratory environments
• Remote/telemedicine consultations (with appropriate clinical oversight)

4 Contraindications and Limitations

4.1 Contraindications

• Use by members of the general public for self-diagnosis or self-treatment
• Emergency, critical care, or life-threatening situations requiring immediate clinical intervention
• Providing definitive medical diagnoses
• Replacing clinical examination, professional judgement, or patient consultation
• Paediatric use without appropriate clinical oversight
• Veterinary use

4.2 Limitations

• The accuracy of outputs depends on the quality and completeness of input data
• The software should be used in conjunction with clinical guidelines and professional expertise
• AI-generated recommendations require verification by qualified healthcare professionals
• The software does not account for all possible patient-specific factors or rare conditions
• Results should be interpreted within the context of the patient's full clinical picture

5 Standards Compliance

HaemoSync has been designed and developed in accordance with the following harmonised standards:

6 Quality Management System

6.1 QMS Overview

BMZ Ethical Investments Ltd maintains a Quality Management System (QMS) compliant with ISO 13485:2016 for the design, development, and maintenance of HaemoSync.

6.2 Key QMS Elements

7 Clinical Safety

7.1 Clinical Evaluation

HaemoSync has undergone clinical evaluation in accordance with MEDDEV 2.7/1 Rev 4 guidance, including:

• Review of relevant scientific literature
• Analysis of clinical data from equivalent devices
• Evaluation of software performance and accuracy
• Assessment of benefit-risk profile

7.2 Clinical Evidence

Validated in partnership with Alderley Lighthouse Laboratory

7.3 Post-Market Clinical Follow-Up

We conduct ongoing post-market clinical follow-up (PMCF) to:

• Monitor clinical performance in real-world use
• Identify any previously unknown risks
• Gather feedback from healthcare professionals
• Update clinical evaluation as new evidence emerges

8 Risk Management

8.1 Risk Management Process

HaemoSync is subject to a comprehensive risk management process in accordance with ISO 14971, including:

• Hazard identification and risk analysis
• Risk evaluation against acceptability criteria
• Risk control measures implementation
• Residual risk assessment
• Benefit-risk analysis
• Production and post-production monitoring

8.2 Key Risk Controls

9 Data Protection Compliance

9.1 UK GDPR Compliance

HaemoSync is designed to support compliance with the UK General Data Protection Regulation (UK GDPR) and Data Protection Act 2018.

9.2 Data Processing Role

10 Information Security

10.1 Security Framework

Our information security management is aligned with ISO 27001:2022 and includes:

10.2 Data Location

10.3 Business Continuity

• Automated backups with geographically redundant storage
• Disaster recovery procedures with defined RTOs and RPOs
• Regular testing of backup and recovery processes

11 Vigilance and Incident Reporting

11.1 Adverse Event Reporting

We maintain a vigilance system for monitoring and reporting adverse events and field safety corrective actions in accordance with MHRA requirements.

11.2 Reporting an Incident

Healthcare professionals or users who experience or become aware of any incident involving HaemoSync should report it to:

11.3 MHRA Reporting

12 Software Lifecycle Management

12.1 Version Control

HaemoSync follows a structured version control system:

12.2 Current Version

12.3 Update Policy

• Security patches are applied promptly
• Users are notified of significant updates via email and in-app notifications
• Release notes are provided for all updates
• Critical safety updates may be applied automatically

13 Training and Support

13.1 User Training

We provide:

• Online user guides and documentation
• Video tutorials
• Onboarding support for new organisations
• Webinars and training sessions (upon request)

13.2 Technical Support

14 Document Availability

The following documents are available upon request:

15 Regulatory Contact

For regulatory enquiries, please contact:

16 Revision History