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Odelle Technology is a consultancy firm specialising in Market Access, adoption, and reimbursement within the Medical Device and MedTech industry across Europe.

Medical Device and Healthcare Technologies:
Regulatory Affairs and Quality Assurance

UOVO Technologies are a full-service consultancy in the digital health, medical devices and healthcare
technologies industry. Our clients are start-ups, pharmaceutical and medical device manufacturers and
consumer products businesses. We offer services in strategy and management consulting, front-end
innovation, technology development, software and product design and development and regulatory
consulting.

Regulatory Affairs & Quality Assurance

We provide support in medical device regulation across the European Union, United States, United
Kingdom, Canada, Australia/New Zealand, Japan, China and India.

Regulatory Affairs

• Global Regulatory Strategy Development
• MDR/IVDR Specialists
• Software as a Medical Device Specialists
• Device qualification, classification and predicate device searches
• Labelling and advertising review
• International registrations and submissions
• Device listing and establishment registration
• Regulatory file letters
• Medical device reporting
• Creation of technical files, design dossiers and design history files
• Post-market support, recall planning and management
• Medical device reporting and complaint handling
• Warning letter resolution
• Inspection advice and management
• Training services
• Audit preparation

Quality Assurance

• Development of ISO9001 and ISO13485 Quality Management Systems
• Development of ISO27001 Information Security Management Systems
• Design control procedures and implementation: Including Health Software Systems (IEC82304,
Software Development IEC62304, Usability Engineering IEC62366)
• Design control audits
• Design development planning
• Design control project management
• DMR (device master record) development
• Risk management program development and implementation per ISO 14971
• Experts in safety critical systems design including Failure Modes and Effects Analysis (FMEA),
Fault Tree Analysis (FTA) and Preliminary Hazard Analysis (PHA)
• Risk Management Plans and Reports
• Risk Analysis
• Risk Control Design
• Medical Device product design history file compliance
• Medical device standards assessment
• Process validation (IQ/OQ/PQ)
• Change management

Contact Us

Get Connected

Call Us

+44 (0) 7804 623 339

Email Us

advice@odelletechnology.com

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