Hindsight | Insight | Foresight

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

Ben Wensley-Stock Consulting 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. We have experience of developing and working within highly regulated environments that are audited to standards such as ISO 13485:2016.  We can provide internal audits and gap analysis AND advise you on strategies to achieve CE marking and FDA clearances at the appropriate time and only when necessary.  Fundamentally our consultants like to understand and solve your problems.

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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