At Rephine, we place utmost importance on delivering a sense of comfort and trust to our clients, leaving them with the assurance that they are compliant with all relevant regulations and standards. With us, you can rest assured that your regulatory compliance needs are taken care of, allowing you to focus on your core business objectives.
We are proud to possess valuable expertise in delivering end-to-end support and solutions to ensure regulatory compliance for medical devices at every stage of the product cycle.
Our services are intricately customisable, tailored to meet the specific needs and requirements of our clients from design and development to manufacturing, marketing, and post-marketing operations.
Expedited compliance processes are made possible through the streamlined compliance roadmaps crafted by our team of experts, saving time and money for both startups and multinational companies.
Our unwavering objective is to achieve success in all of our projects by upholding regulatory standards while prioritizing product safety and performance for patients and users.
For both new products and legacy medical devices, our consultants can facilitate regulatory consulting to place medical devices to market.
Compilation of Technical Documentation following the specific regulatory strategy depending on the regional regulations. We also have significant experience in providing verification evidences such as for Medical Device Software (MDSW) and In Vitro Diagnostic (IVD) Medical Devices.
Medical devices must be managed under a quality system throughout their life cycle. Our extensive QMS expertise will ensure that quality management processes are defined and/or improved, facilitating associated regulatory compliance and continuous improvement.
For small companies we can act as the Person Responsible for Regulatory Compliance (PRRC), being permanently and continuously at your disposal. We can work together to define how to proceed to ensure the responsibilities and also train a person within your organisation to acquire the needed experience to be the internal PRRC in the future.
Be confident with your QMS and with your outsourced activities and suppliers. Our consultants and auditors can bring you the best approach to improve internally and also to qualify your suppliers, specially critical suppliers that would be also audited by the Health Authorities.
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.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.