About
Aurélia is specialized in giving in-depth advice in relation to regulatory compliance and quality. Medical devices and IVDs (incl. software): * Request export certificates (Certificate of a Medical Device, FAGG) * Request CE-mark * Supplier Management * Quality Management System related processes * Lean manufacturing * Quality Risk Management * FMEA * Root Cause Analysis * ISO 13485 (2003, EN 2012, 2016) * ISO 9001 (2008, 2015) * ISO 18113:2011 * ISO 14971:2012 * MEDDEVs * Directive 98/79/EEC ; 93/42/EEC ; * Labeling * Validation * CAPA * Change Control * Internal audit planning * Document Control * QMS GAP analysis * ISO certification * FDA * HIPAA
Technologies
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Google Font API
Mobile Friendly
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Keywords
drugs
quality assurance
risk management
food
regulatory compliance
medical device
cosmetics
pharmaceuticals
cosmetic industry
food industry
product conformity
quality risk management
other scientific and technical consulting services
quality management
quality consulting
regulatory process optimization
regulatory legislation
gmp compliance
product testing
pharmaceutical
gxp compliance
quality standards
b2b
regulatory strategy development
quality system implementation
validation
product regulation
quality systems documentation
healthcare
regulatory inspection readiness
Company Information
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Employees 5
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Founded 2016
Location
54 Deinzestraat, Wortegem-Petegem, Flanders, Belgium, 9790
