Plantafood Medical GmbH is certified according to industry standard DIN EN ISO 13485:2016 by ecm-Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH, Aachen. Subsequently, we are certified for the production of our medical products. ecm conducts an annual audit on-site to ensure the best quality for our customers. We are also certified according to industry standard DIN EN ISO 9001:2015 by the Lacon Institute. Our Quality Management System has been certified according to industry standard DIN EN ISO 9001:2015, meaning that we can meet the highest quality requirements for the contract manufacturing of food supplements, food for special medical purposes, as well as supplementary and individual animal feed for pets.
As a contract manufacturer for food, food supplements, food for special medical purposes (balanced diet), organic products in accordance with the EU-Regulation on Organic Agriculture (Öko-VO), functional food, special food, class I medical devices, cosmetic products, feed supplements and animal feed, regular quality controls are also conducted by the relevant state institutions.
In accordance with Article 29 (1) of Regulation (EC) No 834/2007, we continue to be certified as a processor and importer of organic products by the institution LACON Privatinstitut für Qualitätssicherung und Zertifizierung ökologisch erzeugter Lebensmittel GmbH.
The manufacture of medical devices is regulated by a large number of national and international regulations and standards. The Medical Devices Act is a European law. The product manufacturer is obligated to test and certify the conformity of its product. Depending on the product class, the manufacturer is also obligated to have the product’s technical documentation audited and kept up-to-date. This documentation is audited by a so-called appointed body, following which it is issued with the CE identification number. The registration of medical devices in Germany is managed by the institution DIMDI (Deutsches Institut für Medizinprodukte Dokumentation und Information). The regulations and standards relate both to the product and to the manufacturer's processes and quality management.
We will be happy to handle this service aspect for you - including for your Private Label products as per “medical devices class I”.
Our Quality Assurance Team consists of qualified trophologists, ecotrophologists, biologists, engineers, food technicians, pharmacists and nutritionists, as well as accredited institutes and laboratories. We also work together with German and international universities.
Thanks to our certifications and the approvals we have been granted, you can be sure of documented security for the contract manufacturing of your food supplements, organic products, medical devices, food for special medical purposes, supplementary feed and animal feed.
We are certified according to/for:
Organic products (through LACON): Certifikate
Certificate of good manufacturing practice: Certifikate
FDA (Food and Drug Administration) Certification: Certifikate
We hold permits from the Rhineland-Palatinate state authority for:
We remain at your disposal for all questions concerning product development, formula development, the production and marketing of health products such as food supplements, medical devices Class I, cosmetic products, organic products in accordance with the EU-Regulation on Organic Agriculture (Öko-VO), vital mushrooms, essential oils, food for special medical purposes (balanced diet), special Foods, functional foods, feed supplements and animal feed. Feel free to get in touch and we will be happy to advise you - personally and tailored precisely to your needs.