Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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The design, manufacture and marketing of Medical Devices represents a wide and diversified field of activity within the Life Sciences sector and, as such, subject to compliance to strict and continuous evolving regulatory principles, as we can see, for example, in the new European regulations: 2017/745 and 2017/746.
Rephine will undoubtedly contribute to the success of your projects by ensuring not only the highest levels of regulatory compliance throughout the product life cycle, but also that they will be carried out with the maximum guarantees of safety and performance in the absence of risks for the patient or user of the final product.
From Rephine we offer different assistance services to our clients and partners, all of them focused on accompanying them in the rigorous and efficient fulfillment of all the applicable regulatory requirements for the design, development, production, commercialization and post-market activities of your Medical Devices.
We provide integral support during the development, production, certification, commercialization and post-market follow-up of medical devices, including in-vitro diagnostic products and medical device software (MDSW) in Europe and USA.
We offer different services along the entire value chain of medical devices, aimed at meeting the quality objectives and regulatory requirements in each case.
Marketing process in the United States:
We provide extensive GMP consulting and regulatory services to help keep our clients ahead of the needs and expectations of regulators.
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Telephone:
Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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