Regulatory & Quality

MedTech Regulatory Affairs & Quality Assurance

Integrated and tailored RA/QA solutions that drive MedTech success.

MedTech Regulatory Affairs & Quality Assurance

Backed by 50+ years of direct FDA experience, we offer MedTech regulatory affairs and quality assurance solutions that help innovators achieve and maintain global compliance. From product development to post-market support, our integrated approach equips you to stay ahead of evolving standards while keeping your product pipeline on track. 

Whether you’re launching, scaling, remediating, or acquiring, we deliver the insights and execution needed for long-term regulatory success. 

Ready to stay ahead of the curve? Let’s move your product forward—faster, safer, and with confidence.

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Explore Our Regulatory & Quality Services

Tailored Guidance for Every Stage of Your Product Life Cycle 
No matter where you are in your MedTech journey, our regulatory & quality services are designed to meet your unique challenges. Explore our customized solutions below. 

RQM+ integrates regulatory insight with design and manufacturing quality assurance to ensure your product meets global standards from the ground up. Our experts support design history file (DHF) development, design control optimization, and integration of quality processes into manufacturing environments to minimize risk and ensure compliance.

We provide expert strategy and execution for PMCF to meet evolving EU MDR requirements. Our team develops actionable PMCF plans and reports that satisfy notified body expectations, reduce regulatory delays, and help you continuously monitor product performance and safety in the field.

Our team understands the nuanced requirements for drug-device and biologic-device combinations. We develop regulatory strategies aligned with U.S. FDA and EU expectations, providing expert support across development, submissions, and post-market compliance for combination products.

RQM+ streamlines your CAPA and complaints processes, quickly identifying root causes and implementing sustainable resolutions, reducing compliance risks and enhancing patient safety.

We build and enhance QMS programs that are scalable, inspection-ready, and aligned with ISO 13485, FDA QSR, EU MDR and IVDR, MDSAP, and more. Whether you need support for initial implementation, optimization, or full remediation, we deliver right-sized systems tailored to your operations.

Mergers and acquisitions (M&A) require seamless quality system integration. RQM+ offers proven strategies to consolidate and harmonize QMSs across legacy organizations, minimizing disruption and accelerating compliance across multisite operations. 

Whether you’re navigating regional regulatory challenges or managing global compliance, RQM+ delivers the strategic insights and execution that drive results. Our team of seasoned professionals — including former regulators and industry specialists — brings unmatched experience across therapeutic areas and device types.

We help you establish robust supplier and purchasing controls, ensuring quality throughout your supply chain to consistently meet regulatory expectations and maintain operational excellence.

RQM+ RA/QA consulting encompasses a wide spectrum of specialties with hundreds of industry-leading consultants across the globe. Our strategic acumen and first-hand experience spans medical devices, IVDs, software-enabled products, combination products, and companion diagnostics. RQM+ understands the nuances and decisions our clients confront across device types.

While MedTech regulations continue to evolve, our team remains at the forefront and primed to help our clients navigate RA/QA challenges with business-balanced solutions. 

Why Choose RQM+ for RA/QA Services?

We apply our comprehensive expertise and innovative tools to accelerate your success:

  • Consult with Experts

    Former FDA, notified body, and European regulators become part of your team; largest and most knowledgeable consulting service in the market.

  • Global Success

    Proven track record of submissions across the U.S., Europe, and U.K.

  • Tech-Enabled Advantage

    Technology-driven insights to streamline compliance and documentation.

  • End-to-End Support

    From product concept through post-market management.

  • Personalized Service

    Comprehensive and tailored solutions that address your unique needs and challenges​​.

Proven Success Across MedTech

Join other innovators who trust RQM+ to deliver exceptional results. 

“I wanted to extend my thanks and appreciation for all of the RQM+ team and especially our project lead. I’ve been doing this for almost 20 years with multiple FDA clearances, so I know how nontrivial it is to be a professional in our field. Our project lead is a true expert with significant knowledge, experience and a very balanced common sense. Moreover, they have a rare talent to differentiate between major and minor, and by this to allow the leading team to focus on the more critical aspects of the submission. At the beginning of the project, I’ve evaluated several groups and decided to move forward with RQM+, especially due to the impression I got from our project lead and it proved itself. Again, many thanks and for many more successful projects. Cheers!”

CEO, Innovative MedTech Company

“RQM+ provides unrivaled support and has been instrumental in helping our company achieve its regulatory goals. RQM+ is easy to work with, communicates often, and provides high quality deliverables that exceed expectations. I cannot recommend their services enough!”

Regulatory Compliance Manager, Innovative MedTech Company

“Our quality and regulatory expert is a reliable resource always willing to help and consistently providing clear, actionable responses.”

Senior Regulatory Affairs Specialist, Innovative MedTech Company

“If our regulatory consultant were my only experience with RQM+, I’d be rating her an 11 instead of a 10! Truly excellent.”

Senior Regulatory Affairs Specialist, Innovative MedTech Company

“You have rockstars on your team who are true experts in all things med device regulatory! I have had positive experiences with all RQM+ colleagues and it was reassuring to know the team and their expertise was there for guidance.”

Principal Regulatory Specialist, Innovative MedTech Company

“I was very pleased with the service provided by the 2 regulatory resources that were part of my project. Their level of expertise on the FDA registrations and understanding of the requirements drive us to a successful clearance of 4 different family of products, in addition both of them were always available for consultation within reasonable amount of time.”

Project Engineer, Innovative MedTech Company

Flexible Partnering Solutions

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Outsourcing

Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. Partner with us.

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Consulting

Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+
consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. Partner with us.

Staff Augmentation

Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand
professionals, functional service support, fast deployment for tight timelines, and
contract-to-hire options that integrate seamlessly with your team. Match with a contractor.

Let’s Make MedTech Happen

Partner with RQM+ to turn challenges into opportunities and bring your product to life.

 

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