Greenlight Guru

Created for medical device companies who require
a modern, comprehensive platform for Design Controls and Quality Management

Trusted partners with leading MedTech QMS provider

Where innovation meets efficiency in the world of quality management. Greenlight Guru empower companies with cutting-edge software and comprehensive processes
and user experience, facilitating accelerated growth, enhanced efficiency, and minimised risk throughout the entire product lifecycle.

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How Greenlight Guru can transform your MD processes

Upgrade from outdated paper-based or generic systems to a modern, cloud based solution specially designed for medical devices

The possibilities are endless with tracking quality events, trace design controls to risk, ensure compliance, and more. Greenlight Guru QMS software not only accelerates bringing medical devices to market, but also ensures their sustained success. By choosing a Greenlight Guru system, creates ease of a unified team under one interconnected quality ecosystem with the #1 eQMS for medical device companies.

What services Rephine offer

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Onboarding

We have a powerful and experienced team to
implement Greenlight Guru systems according to regulatory requirements specific to each market.
We align company's processes with
system operations.

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Validation

We have a validation team that helps the customer to validate the configured system according to their requirements and computer system validation policies, following the complete system lifecycle and reducing the time required for Go-Live.

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Training

Rephine can offer ad hoc training to ensure that the overall processes are efficient and compliant with current expectations. This will ensure that your team gets suitable experience and knowledge to maximise the advantages of using the software to elevate your quality and regulatory processes to proficiency levels.

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Ongoing Support

Our Greenlight Guru team of experts can provide maintenance and enhancement assistance to help you maximising the success of your Quality Management System, implementing new processes, improving the existing ones or rolling them out in new sites, divisions or business areas.

Greenlight Guru Quality

Processes our Rephine experts can implement

 

Optimise Document Management for Enhanced Traceability

Shift from paper to cloud-based platforms for accurate management of Medical Device documentation. Embrace a comprehensive end-to-end approach through Rephine and Greenlight Guru collaboration to eliminate silos, ensure high-standard compliance, and streamline daily activities. Choose a tailored Document Management plan for seamless navigation of regulatory complexities and confident delivery of innovative Medical Devices.

GG Document Management

 

Create Efficiency with Organised Tasks Effortlessly

Enhance timelines and efficiency with Product Management & Design Controls. Our Greenlight Guru experts implement compliant and organised records by automating tasks like design control matrices, order changes, BOMs, and DHFs. We ensure comprehensive BOM control, multi-level structures, and organised product families, ensuring successful collaborations, high-standard compliance, and regulatory submissions for ISO certifications.

GG Product Development

 

Accurate Risk Management in a Compliant Ecosystem

Leverage the expertise of our Greenlight Guru team for a quality and regulatory perspective on Risk Management. Enjoy seamless integration with full traceability in your QMS. Effortlessly integrate risk-based thinking across your device ecosystem, ensuring compliance with ISO 14971:2019 and ISO 13485:2016. Whether creating Risk Management Files or managing post-market risks, our experts have you fully covered.

GG Risk Management

 

Ease Quality & CAPA Burden with Innovative Solutions

Integrate the Quality Process & CAPA Management system, specificially designed to efficiently handle MedTech CAPAs. Collect data, documents, design components, and quality events within your QMS, ensuring proactive planning with traceable and compliant workflows for effective issue correction and prevention. Automate your CAPA process to simplify it, and tailor custom workflows that align with your specific needs.GG Quality Process and CAPA Management

Greenlight Guru's strategic partnership with Rephine enhances global value and quality for medical device companies, integrating leading solutions, and in-house expertise to optimise operations, navigate regulations, and deliver innovative devices, as highlighted by partnership thought leaders.

Discover more from the official launch below

REPHINE SPEECH MARKS OPEN MEDICALDEVICES

Client Commitment

We’re dedicated to advancing our medical device division, especially for niche and start-up companies. 

By extending our services of implementation and improvement of Quality Management Systems (QMS) for Medical Devices, to the
automation and optimisation of key quality processes, our commitment is to ensure we are implementing the best MDQMS platforms
available today.

As a result, a clear benefit for our clients implementing Greenlight Guru Quality:

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Robust, reliable and fully compliant Quality System processes

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Transparency and visibility of quality records

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Efficient operational workflows designed according to both best practices
for each industry and to customers’ organisations at a time

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Compliance with Part 11 CFR Part 820 and ISO 13485

Meet the Greenlight Guru Experts

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Victor Samitier

QMS Delivery Lead &
QMS Area Manager

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Núria de la Fuente

Medical Device Senior Consultant
& MD Area Manager

If you'd like to find out more about Greenlight Guru and how Rephine can help your MD QMS systems

Get in touch with us today to arrange a free 30 minute consultation with our experts

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Looking to further develop your MD and MDSW quality assurance journey?

Our Medical Device experts can provide ongoing assistance with customisable QMS systems, regulatory consultancy, and more, to help with your QA journey.

Discover our other Medical Device Services and how are experts can help you.

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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

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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