With over 50 years of direct experience with the FDA, RQM+ provides regulatory affairs and quality assurance solutions for MedTech that assist innovators in achieving and sustaining global compliance.
RQM+’s comprehensive approach, which spans from product development to post-market support, empowers users to remain proactive in adapting to changing standards while ensuring the product pipeline remains on schedule.
Regardless of whether users are launching, scaling, remediating, or acquiring, RQM+ offers the necessary insights and execution for enduring regulatory success.
Prepared to stay ahead of the curve? It is possible to move the product forward – faster, safer, and with confidence.
Explore regulatory and quality services
Tailored guidance for every stage of the product life cycle
Regardless of the position in the MedTech journey, RQM+ regulatory and quality services are tailored to address the specific challenges.
Design quality engineering and manufacturing QA
RQM+ combines regulatory knowledge with quality assurance in design and manufacturing to guarantee that the product adheres to global standards from the outset.
RQM+ specialists assist in the development of design history files (DHF), optimize design control, and incorporate quality processes into manufacturing settings to reduce risk and ensure compliance.
Post-market clinical follow-up (PMCF)
RQM+ offers specialized strategy and implementation for Post-Market Clinical Follow-up (PMCF) to comply with the changing requirements of the EU Medical Device Regulation (MDR). The RQM+ team formulates practical PMCF plans and reports that meet the expectations of notified bodies, minimize regulatory delays, and help users consistently monitor product performance and safety in the market.
Combination products regulatory support
The RQM+ team understands the complex requirements associated with drug-device and biologic-device combinations. RQM+ formulates regulatory strategies that align with the expectations of the US FDA and the EU, providing expert assistance throughout the development process, submissions, and post-market compliance for combination products.
CAPA and complaints
RQM+ optimizes the CAPA and complaints procedures, swiftly pinpointing root causes and executing sustainable solutions, minimizing compliance risks and improving patient safety.
Quality management systems
RQM+ develops and improves Quality Management System (QMS) programs that are scalable, ready for inspection, and compliant with ISO 13485, FDA Quality System Regulations (QSR), EU Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR), Medical Device Single Audit Program (MDSAP), among others.
Acquisition integration and quality system harmonization
Mergers and acquisitions (M&A) necessitate the smooth integration of quality systems. RQM+ provides established strategies to unify and align Quality Management Systems (QMSs) across legacy organizations, reducing disruption and expediting compliance across multiple site operations.
Proven global regulatory success
Whether users are addressing regional regulatory challenges or overseeing global compliance, RQM+ provides the strategic insights and execution necessary to achieve results. RQM+’s team of experienced professionals, which includes former regulators and industry experts, offers unparalleled expertise across various therapeutic areas and types of devices.
Supplier and purchasing controls
RQM+ helps users implement robust supplier and procurement controls, ensuring quality throughout the supply chain to meet regulatory requirements and maintain operational excellence consistently.
RQM+ RA/QA consulting covers a broad range of specialties, featuring hundreds of top-tier consultants worldwide. RQM+ strategic insight and practical experience encompass medical devices, in vitro diagnostics (IVDs), software-enabled products, combination products, and companion diagnostics. RQM+ is well aware of the complexities and choices the clients face across various device categories.
As MedTech regulations continue to evolve, the RQM+ team remains at the forefront, ready to assist clients in overcoming RA/QA challenges with solutions that strike a balance between business needs.
Why choose RQM+ for RA/QA services?
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RQM+ utilizes the extensive knowledge and cutting-edge tools to expedite the success:
Consult with experts
Previous FDA officials, notified bodies, and European regulators join the team; the largest and most knowledgeable consulting service available in the market.
Global success
Proven history of submissions throughout the US, Europe, and the UK.
Tech-enabled advantage
Insights driven by technology to enhance compliance and documentation.
End-to-end support
From the initial product concept to the management after it has entered the market.
Personalized service
Thorough and customized solutions designed to meet the specific needs and challenges.
Proven success across MedTech
Join other innovators who trust RQM+ to deliver exceptional results.
Flexible partnering solutions
Outsourcing
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Outsourcing solutions tailored to projects, functions, or parts of functions, offering scalability. Utilize RQM+'s expertise and adaptability, allowing teams to concentrate on core business areas, objectives, and innovation.
Consulting
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RQM+ offers specialized MedTech expertise to achieve specific results. RQM+'s consultants provide practical advice and hands-on support for prompt problem-solving.
Staff augmentation
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RQM+ offers MedTech talent to address skill shortages. RQM+ delivers on-demand experts, functional support, rapid deployment, and contract-to-hire options for team integration.
Let’s make MedTech happen
Collaborate with RQM+ to transform challenges into opportunities and bring the product to life.