{"id":2190,"date":"2026-10-17T03:47:44","date_gmt":"2026-10-17T02:47:44","guid":{"rendered":"https:\/\/www.medgenix.eu\/?page_id=2190"},"modified":"2026-10-17T06:57:35","modified_gmt":"2026-10-17T05:57:35","slug":"kwaliteitsnaleving","status":"publish","type":"page","link":"https:\/\/www.medgenix.eu\/nl\/quality-compliance\/","title":{"rendered":"Kwaliteit en naleving"},"content":{"rendered":"
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\n\t\t\t\t\tKwaliteit en naleving\n<\/span>\t\t\t\t<\/div>\n\t\t\t\t
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Quality Built Into<\/span> Every Step<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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At Medgenix, quality is not a checkpoint. It is embedded throughout every stage of development, manufacturing, packaging and product release.<\/p>

Our independent Quality organization ensures that products are developed, manufactured and released in compliance with the highest regulatory and industry standards. Through a strong focus on quality, compliance and continuous improvement, we help customers bring safe, effective and reliable products to market.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\"Quality is not an act, it is a habit.\"<\/p>\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\tAristotle<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\tQuality & Compliance Journey<\/span>\t\t\t\t<\/div>\n\t\t\t\t
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Quality built into<\/span> every step<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\tQuality systems shield<\/title><\/path><\/path><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Quality Systems<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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GMP, ISO 13485, quality culture, risk management, continuous improvement<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\tQuality assurance clipboard<\/title><\/path><\/path><\/rect><\/path><\/path><\/path><\/circle><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Quality Assurance<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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Supplier qualification, validation, audits, change control, CAPA, batch release<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Quality Control<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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Chemical testing, microbiological testing, in-process testing, finished product testing, stability studies<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Regulatory Compliance<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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EU GMP, MIA, GDP, medical device compliance, inspection readiness<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tEU GMP Certified\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tISO 13485 Certified\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tIndependent QA & QC\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Quality Assurance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Ensuring Compliance. Protecting Quality.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Our independent Quality Assurance team oversees every stage of the product lifecycle, supporting pharmaceutical products, medical devices and cosmetics.<\/p>

From supplier qualification and process validation to audits, batch certification and regulatory compliance, Quality Assurance ensures that our systems remain robust, compliant and inspection-ready.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Our Quality Assurance Expertise<\/h3>\t\t\t\t<\/div>\n\t\t
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GMP and ISO compliance management<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Supplier qualification and oversight<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Quality risk management<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Validation and qualification programs<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Audit preparation and support<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Change control management<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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CAPA management<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Batch review and release<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Continuous improvement initiatives<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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By maintaining strong quality systems and proactive risk management practices, we help ensure product quality, regulatory compliance and operational reliability.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Medgenix\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\tQuality Control<\/span>\t\t\t\t<\/div>\n\t\t\t\t
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Quality Control<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Validated Data. Trusted Results.<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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Our state-of-the-art Quality Control laboratories provide both chemical and microbiological testing to support product quality throughout development, manufacturing and commercial supply.<\/p>

The Quality Control team verifies, tests and documents product quality at every critical stage of the process.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Quality Control Services<\/h3>\t\t\t\t<\/div>\n\t\t
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Incoming Material Testing<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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Verification of incoming raw materials and packaging components to ensure compliance with predefined specifications.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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In-Process Testing<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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Monitoring of intermediate and bulk products during manufacturing to ensure process consistency and product quality.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Finished Product Testing<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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Comprehensive testing of finished products against registered specifications, technical documentation and customer requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Stability Studies<\/h6>\t\t\t\t<\/div>\n\t\t\t\t
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Stability programs performed in accordance with ICH guidelines to support product development, registration and lifecycle management.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\tBeyond routine testing\n<\/span>\t\t\t\t<\/div>\n\t\t\t\t
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Supporting Innovation and Continuous Improvement<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Beyond routine testing, our Quality Control team actively supports:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Analytical method development<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Method validation<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Investigation activities<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Process optimization initiatives<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Product improvement programs<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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This close collaboration between Quality, Development and Manufacturing helps accelerate innovation while maintaining compliance and product integrity.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t Regulatory Compliance<\/span>\t\t\t\t<\/div>\n\t\t\t\t
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Licenses & Certifications\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Our quality systems operate within a regulated environment supported by internationally recognized licenses and certifications.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Pharmaceutical Products<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tManufacturing Authorisation (MIA) for Medicinal Products for Human Use and Investigational Medicinal Products for Human Use\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tNon-sterile manufacturing and packaging of liquids and semi-solids\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tEU GMP Certificate\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tGDP Certificate for Distribution of Active Substances Used as Starting Materials\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Medical Devices<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tISO 13485:2016 Certification\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tManufacturing of non-sterile liquid medical devices\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Confidence Through Quality<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Our customers rely on Medgenix because quality is integrated into every aspect of our operations.<\/span><\/p>

By combining scientific expertise, operational excellence and a pragmatic approach to compliance, we help ensure that products are safe, effective and ready for successful commercialization.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tOntwikkeling\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tProductie\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h6>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tProduct release\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h6>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Talk to our Quality team<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Whether you require development support, manufacturing oversight, analytical testing or regulatory compliance expertise, our Quality organization provides the foundation for reliable and sustainable product success.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tNeem contact op met ons team<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Quality & Compliance Quality Built Into Every Step At Medgenix, quality is not a checkpoint. It is embedded throughout every stage of development, manufacturing, packaging and product release. Our independent Quality organization ensures that products are developed, manufactured and released in compliance with the highest regulatory and industry standards. Through a strong focus on quality, […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"footnotes":""},"faq-category":[],"class_list":["post-2190","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/pages\/2190","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/comments?post=2190"}],"version-history":[{"count":47,"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/pages\/2190\/revisions"}],"predecessor-version":[{"id":2246,"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/pages\/2190\/revisions\/2246"}],"wp:attachment":[{"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/media?parent=2190"}],"wp:term":[{"taxonomy":"faq-category","embeddable":true,"href":"https:\/\/www.medgenix.eu\/nl\/wp-json\/wp\/v2\/faq-category?post=2190"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}