Compliance Centre
Our Commitment
At Titania Medical, patient safety, quality, regulatory compliance, information security, and ethical business practices are fundamental to everything we do.
We are committed to operating in accordance with applicable United Kingdom legislation, including the UK General Data Protection Regulation (UK GDPR), the Data Protection Act 2018, and all applicable medical device regulations governing the products and services we provide.
Our objective is to deliver innovative, patient centred medical solutions while maintaining the highest standards of integrity, quality, confidentiality, traceability, and continual improvement.
Every member of our organisation shares responsibility for maintaining compliance and ensuring that our products and services consistently meet the expectations of healthcare professionals, patients, regulatory authorities, and business partners.
Quality Management
Quality is embedded throughout every stage of our organisation.
Our quality management processes are designed to ensure that products and services consistently meet customer expectations, regulatory requirements, and recognised quality management principles.
We are committed to:
• Continual improvement.
• Risk based decision making.
• Staff competence and ongoing training.
• Documented procedures and controlled records.
• Product traceability.
• Customer satisfaction.
• Effective complaint management.
• Regulatory compliance.
Quality is continuously monitored and reviewed to support safe, reliable, and effective medical solutions.
Regulatory Compliance
Titania Medical supplies medical devices in accordance with applicable United Kingdom medical device legislation.
Where applicable, products are supplied in compliance with the regulatory requirements governing both standard and custom made medical devices.
We work closely with manufacturers, regulatory specialists, clinicians, and healthcare organisations to ensure that every product supplied meets the applicable legal, technical, and clinical requirements.
Compliance is integrated throughout our design, manufacturing, quality assurance, documentation, distribution, and post market activities.
Custom Made Medical Devices
Titania Medical specialises in patient specific custom made medical devices designed exclusively for individual patients following receipt of a valid prescription from an appropriately qualified healthcare professional.
Each custom made implant is individually designed, technically reviewed, manufactured, inspected, documented, and supplied specifically for one identified patient.
Every project follows a structured workflow that includes:
• Clinical prescription review.
• Assessment of CBCT, DICOM, STL files, intraoral scans, photographs, and other clinical information.
• Patient specific implant design.
• Technical design review.
• Manufacturing verification.
• Final quality inspection.
• Regulatory documentation.
• Secure delivery.
Every custom made implant is fully traceable throughout its entire lifecycle.
Design Verification and Risk Management
Patient safety remains our highest priority throughout every project.
Each patient specific design undergoes a structured technical review to verify:
• Anatomical adaptation.
• Mechanical stability.
• Prosthetic compatibility.
• Manufacturing feasibility.
• Compliance with the clinical prescription.
Risk management principles are applied throughout the design, manufacture, supply, and post market phases to minimise risk and support safe clinical outcomes.
Data Protection & Privacy
Titania Medical is committed to protecting the privacy and confidentiality of all personal information entrusted to us.
Personal information is processed lawfully, fairly, transparently, and only for legitimate business, regulatory, and healthcare related purposes.
Our data protection procedures ensure that personal information is:
• Collected only where necessary.
• Processed securely.
• Protected against unauthorised access.
• Retained only for as long as legally or operationally required.
• Securely deleted or destroyed when no longer required.
For further information, please refer to our Privacy Policy and Data Protection Policy.
Clinical Data Security
We recognise that patient clinical information requires the highest level of protection.
Clinical data, including CBCT scans, DICOM files, STL files, intraoral scans, clinical photographs, and associated patient information, are handled securely in accordance with UK GDPR and our internal Information Security procedures.
Access to confidential information is restricted to authorised personnel with legitimate business or clinical responsibilities.
Information Security
Titania Medical has implemented appropriate organisational, administrative, and technical safeguards to protect confidential information belonging to patients, clinicians, employees, suppliers, and business partners.
Our information security procedures are regularly reviewed to reduce the risk of accidental or unlawful loss, disclosure, alteration, misuse, or unauthorised access.
Employees are expected to maintain strict confidentiality and comply with all applicable information security and data protection requirements.
Traceability
Traceability is maintained throughout the complete lifecycle of every custom made medical device.
Documented records are maintained for design activities, manufacturing, quality inspections, regulatory documentation, distribution, customer communication, and complaint handling.
This enables complete identification and traceability of every patient specific device supplied by Titania Medical.
Complaints, Vigilance & Post Market Surveillance
Titania Medical encourages customers to report any concerns regarding our products or services.
All complaints are investigated promptly, objectively, and confidentially.
Where appropriate, incidents involving medical devices are managed in accordance with applicable vigilance reporting requirements.
Customer feedback, complaint trends, and clinical experience are continuously monitored to support post market surveillance, risk management, and continual improvement.
Data Retention
Information is retained only for the period necessary to satisfy legal, regulatory, contractual, operational, and quality management requirements.
When retention periods expire, records are securely deleted or destroyed using appropriate methods to maintain confidentiality and information security.
Ethical Business Practices
Titania Medical is committed to conducting business honestly, ethically, professionally, and transparently.
We promote integrity, accountability, fairness, respect, confidentiality, and compliance throughout all relationships with healthcare professionals, patients, suppliers, distributors, regulatory authorities, and business partners.
Environmental Responsibility
Titania Medical is committed to reducing the environmental impact of its activities wherever reasonably practicable.
We encourage responsible use of resources, appropriate waste management, continual improvement, and environmentally responsible business practices throughout our operations.
Business Continuity
We recognise the importance of maintaining continuity of service to healthcare professionals and patients.
Appropriate procedures are maintained to minimise operational disruption and support the continued delivery of products and services whenever reasonably possible.
Continuous Improvement
Compliance is an ongoing commitment rather than a single achievement.
Our policies, procedures, management systems, and operational processes are regularly reviewed to support continual improvement, regulatory compliance, patient safety, product quality, and customer satisfaction.
Contact
For enquiries relating to compliance, regulatory affairs, data protection, information security, or quality management, please contact:
Titania Surgical Ltd
Trading as Titania Medical
19 Oxford Road
Regus Offices
Bournemouth
BH8 8GS
United Kingdom
Telephone: +44 1202 934 400
Email: contact@titaniamedical.com