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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 services to help keep our clients ahead of the needs and expectations of regulators.
Blog From repeatable rigour and experienced expertise, to highly ethical and transparent practices Alasdair Leckie, VP Audit Services, Rephine As in any other area of life …
Pharmaoffer, the ‘Amazon’ of API suppliers, will link its customers to Rephine’s vast library of live, off-the-shelf GMP audit reports of manufacturers around the world …
Article Live online event to be held on April 17th-18th 2023 and will feature deep domain expertise within the scope of Quality Assurance. Stevenage, Hertfordshire, 27th …
Article The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …
Blog EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …
Article Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity. …
Blog An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …
Article Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …
Article Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …
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