QUALITY
MANAGEMENT
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Quality Management Systems in compliance with ISO 13485, ISO 27001, MDSAP, 21 CFR 820 and MDR 2017/745
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Improvement, scale-up and maintenance of management systems
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Quality Management Systems Group Training
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ISO 13485, ISO 14971, IEC 62304, ISO 27001 and ISO 45001 Training Programs
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Verification and Validation
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Software Validation
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Sterilisation Validation per ISO 11137
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ISO 14971-compliant Risk Management
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Internal Auditing for ISO 13485, ISO 14971, ISO 27001 and ISO 45001 compliance
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External Audit Management
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ISO 13485, ISO 27001 and ISO 45001 Certification Support
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Quality Administrative support
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Regulatory Assessments of all medical technologies
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Global Regulatory Strategy Development for all key markets
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Medical Device Technical File and Design Dossier review and/or curation
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Global regulatory submissions, including EU, AUS and US jurisdictions
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Management of key regulatory stakeholder communications
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Post Market Surveillance, medical device vigilance and incident reporting
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Product recall and advisory notice management
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Australian Regulatory Agent work on behalf of an existing local sponsor
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Regulatory administrative support.
REGULATORY
AFFAIRS
OPERATIONS
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Early-stage strategic planning and advice
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Contract operations and management services
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Compliance assessments of commercialisation activities, including advertising and marketing
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Optimisation of lean business operations
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Go-to-Market Strategies and Workshopping
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Information Security Risk Management for HR
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HR solutions for operations in regulated MedTech spaces
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HR documentation management systems