{"id":226,"date":"2020-03-31T11:05:10","date_gmt":"2020-03-31T09:05:10","guid":{"rendered":"https:\/\/www.fresco.es\/international\/?page_id=226"},"modified":"2020-12-03T10:22:04","modified_gmt":"2020-12-03T08:22:04","slug":"quality-certifications","status":"publish","type":"page","link":"https:\/\/www.fresco.es\/international\/fresco\/quality-certifications\/","title":{"rendered":"Quality & Certifications"},"content":{"rendered":"

Quality & Certifications<\/strong><\/h1>\n\n

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FRESCO holds the Medical Manufacturer Licence 7521-PS<\/strong> as a manufacturer audited by the Spanish Agency for Medical Devices and Pharmaceuticals. <\/h3>

Additionally Fresco complies with latest Quality Management standards. Including ISO 9001:2015<\/strong>, ISO 13485:2016<\/strong> (medical devices) and ISO 22716:2007<\/strong> (cosmetic products).<\/p>

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Our polymer gel complies with the CE regulations<\/strong> for biological evaluation of medical devices according to ISO 10993<\/strong>.<\/h4>

Biocompatibility <\/strong>& ISO 10993<\/strong> Medical Device Test<\/strong><\/h2>

Skin irritation test: ISO 10993-10<\/strong>
Analysis of intracutaneous reactivity: ISO 10993-10<\/strong>
Skin sensitisation study: Buehler test in compiliance with UNE-EN iSO 10993-109<\/strong>
Citotoxicity assay: ISO 10993-5<\/strong><\/h4>

All Fresco\u2019s manufactured medical products have CE<\/strong> marking.
The company is FDA<\/strong> registered.<\/p>

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Quality & Certifications FRESCO holds the Medical Manufacturer Licence 7521-PS as a manufacturer audited by the Spanish Agency for Medical Devices and Pharmaceuticals. Additionally Fresco complies with latest Quality Management standards. Including ISO 9001:2015, ISO 13485:2016 (medical devices) and ISO 22716:2007 (cosmetic products). Our polymer gel complies with the CE regulations for biological evaluation of … Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":119,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-226","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/pages\/226","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/comments?post=226"}],"version-history":[{"count":23,"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/pages\/226\/revisions"}],"predecessor-version":[{"id":2492,"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/pages\/226\/revisions\/2492"}],"up":[{"embeddable":true,"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/pages\/119"}],"wp:attachment":[{"href":"https:\/\/www.fresco.es\/international\/wp-json\/wp\/v2\/media?parent=226"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}