Driven by patient safety and medical device excellence
At Rephine MedTech, 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.
We provide integral support for all stages of product and software lifecycle, including in-vitro diagnostic products and medical device software (MDSW) in Europe and USA. With us, you can rest assured that your medical device (MD) regulatory compliance needs are taken care of, allowing you to focus on your core business objectives.
We deliver end-to-end support and solutions to ensure regulatory compliance for medical devices at every stage of the product cycle
Comprehensive Compliance
Our Regulatory and Quality Solutions excel in providing end-to-end support and valuable advisory services, guaranteeing that your medical devices and medical device software (MDSW) adhere to regulatory standards at every stage of their lifecycle.
Tailored Precision
At the core of our strengths is the ability to offer intricately customisable services. From design and development to manufacturing, marketing, and post-marketing operations, our solutions are precisely tailored to meet the unique needs of our clients.
Streamlined Processes
Experience streamlined compliance processes with our expert team’s crafted roadmaps. This not only ensures adherence to regulations but also saves valuable time and resources for both startup ventures and multinational corporations.
Gold Standard Success
Our commitment extends beyond compliance to an unwavering dedication to project success. Upholding regulatory standards is our priority, ensuring product safety and performance for the well-being of patients
and users.
We offer different services along the entire value chain of medical devices, aimed at meeting the quality objectives and regulatory requirements in each case.
Extensive areas our experts can support with on your MD journey
For both new products and legacy medical devices, our consultants can facilitate regulatory consulting to place medical devices to market:
Regulatory RoadmapsMedical Device classificationMDR / IVDR checklist readinessProduct Risk assessment: ISO 14971 methodologyGap remediation of defficiencies from NB / Health Authority review / inspectionAd-hoc consultingMedical devices must be managed under a quality system throughout their life cycle. Our extensive Quality Management Systems (QMS) expertise will ensure that quality management processes are defined and/or improved, facilitating associated regulatory compliance and continuous improvement:
Implementation of QMS (ISO 13485 & 21 CFR 820): supporting you to QMS certification
Internal Audis/GAP Assessment: getting you ready for QMS certification
Suppliers Approval: supplier managements and worldwide supplier audit
QMS Certification back office
Non conformities and CAPA management
e confident with your QMS and your outsourced activities and suppliers. Our consultants and auditors can bring you the best approach to improve internally and also to qualify your suppliers, especially critical suppliers that would also be audited by the Health Authorities:
QMS Internal Audits
FDA mock inspections
Notified Body back office support
QMS or Technical File gap assessments
Supplier audit/supplier qualification
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.:
Compilation of Technical Documentation
Define claims for intended use and device description chapter Product Risk assessment
How to evidence and justify General Safety and Performance Requirements (GSPR) and applicable standardsReview of labels and Instructions for UseDesign and Development DocumentationFunctional verification for Medical Device Software Analytical Performance for IVD productsManufacturing/sterilisation process validationPost Market Surveillance plans and reports
Need to discuss one of the areas above for a project? We are only one discovery call away.
We offer free 30 minute discovery calls so we can understand your QA requirements for any project. Whether you're just starting out in the Medical Device field, or an established enterprise, we've got you covered.
Upgrade to a modern, cloud based Medtech system
Empower your growth in MedTech with Greenlight Guru, the #1 eQMS specifically designed for medical device companies.
Our Medical Device and QMS experts can support you in implementing Greenlight Guru’s cutting-edge software, ensuring global QA compliance standards. Together, we can transform your MD quality ecosystem into a seamless and sustainable platform, achieving unparalleled efficiency.
Did you know we can be your trusted PRRC?
For small medical device and MDSW 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.
Meet the Medical Device experts
Connect with Maria Dolores today
Where do you Need our Help?
For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Global Audit Library
Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit
GMP Audit Services
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
GxP Consultancy
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
Digitalisation
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
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REPHINE HQ
- Stevenage, UK
- +44 1763 853135
REPHINE BARCELONA S.L.U
- Barcelona, Spain               Â
- +34 934 178065
REPHINE CHINA
- Shanghai, ChinaÂ
REPHINE INDIA
- Hyderabad, India                Â