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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.

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We deliver end-to-end support and solutions to ensure regulatory compliance for medical devices at every stage of the product cycle

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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.

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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.

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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.

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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.

Development

Production

Certification

Commercialisation

Post-market

Extensive areas our experts can support with on your MD journey

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For both new products and legacy medical devices, our consultants can facilitate regulatory consulting to place medical devices to market:

Rephine TickRegulatory Roadmaps

Rephine TickMedical Device classification

Rephine TickMDR / IVDR checklist readiness

Rephine TickProduct Risk assessment: ISO 14971 methodology

Rephine TickGap remediation of defficiencies from NB / Health Authority review / inspection

Rephine TickAd-hoc consulting

Medical 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:

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Implementation of QMS (ISO 13485 & 21 CFR 820): supporting you to QMS certification

Rephine TickInternal Audis/GAP Assessment: getting you ready for QMS certification

Rephine TickSuppliers Approval: supplier managements and worldwide supplier audit

Rephine TickQMS Certification back office

Rephine TickNon conformities and CAPA management

Be 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:

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QMS Internal Audits

Rephine TickFDA mock inspections

Rephine TickNotified Body back office support

Rephine TickQMS or Technical File gap assessments

Rephine TickSupplier 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.:

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Compilation of Technical Documentation 

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Define claims for intended use and device description chapter Product Risk assessment

Rephine TickHow to evidence and justify General Safety and Performance Requirements (GSPR) and applicable standards 

Rephine TickReview of labels and Instructions for Use

Rephine TickDesign and Development Documentation

Rephine TickFunctional verification for Medical Device Software 

Rephine Tick Analytical Performance for IVD products

Rephine Tick Manufacturing/sterilisation process validation

Rephine TickPost Market Surveillance plans and reports

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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.

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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.

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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

Our experienced team of medical device consultants act as a partner ensuring regulatory compliance and quality assurance. We are driven by our enthusiasm to bring safe, effective and innovative medical devices to market.

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Connect with Núria today

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We can provide consultancy and regulatory advice in current and innovative areas, always adapting to the requirements of each client and seeking to adopt the best solution for your company
Núria de la Fuente
Medical Device Senior Consultant
& MD Area Manager
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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.

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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

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GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

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GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

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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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Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
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