Regulatory Affairs Support from Expert Implementers
RQM+ has IVD industry experts and we have the leadership and expertise to get your safe and effective product(s) to market. Our risk-balanced approach and strategic direction contribute to positive business impacts and set your organization up for greater success.

We provide IVD expert regulatory resources for projects of all sizes.

    IVD expert regulatory resources

RQM+ employs global thought leaders who have dedicated their careers to IVD regulatory affairs and quality assurance. Our team understands how IVDs work, how performance is measured, and what type of documentation is required. With former regulators and notified bodies on staff, we have unique insights into what reviewers are looking for in your submissions.

We understand the reality that some IVD products are more profitable than others, which is why we take a business-balanced approach to providing strategic direction. We work with you to evaluate factors such as risk, market performance, and business goals, helping prioritize product updates and launches to meet evolving regulations and standards.

Our engineers and scientists have the technical and regulatory expertise you need on your team from the beginning when developing new products. Services include developing and updating regulatory strategy, aligning regulatory activities and business strategies, evaluating risk, providing regulatory review and input on product development documentation, and creating an efficient pathway to market.

The unrivaled collective knowledge at RQM+ allows us to provide expert support for IVD regulatory submissions, including FDA 510(k), PMA, IDE, EUA, breakthrough, and pre-submissions. Whether you need support for a single product, platform technology, or multiple product lines, we’re here for you.

RQM+ recognizes the vital role of quality systems for IVD manufacturers, emphasizing compliance with standards like ISO 13485 for regulatory adherence and product excellence. We prioritize risk management and continuous improvement, essential for mitigating potential hazards and enhancing products and processes. This commitment not only secures market access but also builds lasting trust with stakeholders, crucial for the sustained success of IVD manufacturers in the healthcare industry.

RQM+ has been at the forefront of the transition of the industry to in vitro diagnostic regulation (IVDR), with client-validated processes and tools to ensure compliance and keep your product(s) on the market. From strategy through detailed tactical execution, our expert implementers have experience in transitioning multinational organizations to IVDR for all IVD classes. Gap assessments, post-market documentation, and more are part of the suite of services we offer to get your products on the market and maximize your return on investment.

At RQM+, we offer specialized sustaining support for IVD manufacturers, ensuring their products consistently adhere to the highest standards of quality and regulatory compliance. Our services are tailored to the unique needs of the IVD sector, encompassing ongoing regulatory guidance, quality system optimization, and post-market surveillance. This focused approach helps maintain product integrity, ensures continuous compliance with evolving standards like ISO 13485, and supports the longevity and market success of IVD products. Our expertise in the IVD landscape positions us to effectively address the specific challenges and opportunities, providing our clients with the assurance and support they need for sustained growth and excellence.

RQM+ benefits
Subject Matter Expert Support

Subject Matter Expert Support

Add SME capacity to your internal team for specific projects, such as a 510(k) submission or all things regulatory for assigned product lines.

Client-Validated Processes

Client-Validated Processes

Constantly evolving best practices and collective knowledge ensure an efficient path to compliance.

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Project Management

For large programs, RQM+ project managers work with you to define the project scope, develop the plan and schedule, and lead the team of combined resources to ensure the project is delivered efficiently and successfully.

When you work with RQM+ you benefit from our IVD expertise, IVD thought leadership, and commitment to being an extension of your business.

Learn more about the RQM+ approach

We provide business value, with industry-leading subject matter experts who work across functions and align deliverables for submission.

Technical Documentation for IVDs

We have created hundreds of technical documentation files across all device classes. Our global team has the clinical and regulatory expertise to ensure your documents meet the high standards of reviewers.

Complete IVDR Transition

The required transition to IVDR has shaken up the industry, and RQM+ takes a proactive approach to understanding challenges and creating strategic plans to overcome them. We start with an impact assessment, align all of the necessary resources for a successful transition, identify the gaps in documentation, create a remediation plan, and execute it to keep your products on the market.

Regulatory Intelligence Monitoring 

Global IVD regulations are constantly evolving and are experts are always at the leading edge. RQM+ monitors legislation implementation, new guidance, industry calibration, notified body feedback, and lessons learned from projects we complete throughout the world. Our team also has a lot of projects under their belt, so RQM+ is well-equipped to support a variety of IVDs and scenarios.

When your internal regulatory affairs team is overwhelmed, RQM+ immediately refines processes and fills skills gaps with our expert resources. We also collaborate with you to build in-house skills and capabilities to deliver transformative solutions.

Industry Leadership

Industry Leadership
Former FDA Center for Devices and Radiological Health (CDRH) and notified body leadership on staff provide valuable insights into reviewer expectations.

Client-Validated Processes

Client-Validated Processes
Constantly evolving best practices and collective knowledge ensure an efficient path to compliance.

Innovative Approach

Innovative Approach
Business-balanced solutions ensure smart portfolio and lifecycle management that supports organizational goals.

Explore IVD Regulatory Affairs by Region

IVD Regulatory Affairs in the US

From leading pre-market strategy to ensuring post-market compliance—and all of the regulatory submissions in between—RQM+ supports regulatory affairs teams throughout the product life cycle. With former FDA CDRH and seasoned RA experts on our team, we know what reviewers look for. This allows us to draft submissions that generate fewer questions and get your products to market faster.

IVD Regulatory Affairs in the EU

EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) has many manufacturers struggling to comply. RQM+ has been involved from the beginning, providing complete transition solutions that keep our clients’ products on the market. We promise you - it's tougher than it looks. The former notified body leadership on our team gives our experts valuable insights into successfully implementing IVDR for all types of IVDs.

Global Medical Device Regulatory Affairs

RQM+ works with your in-country representatives to identify requirements and submission/registration strategies, and we interpret those requirements for your product development teams. This ensures design and testing will meet the expectations of regulatory bodies, and your product will be globally marketed. RQM+ creates submission content in support of your global regulatory affairs teams, expanding your product market to the rest of the world.

Video FAQs About IVD Regulatory Affairs

What are some best practices for defining your intended purpose statement under IVDR?

The guidance that would be most helpful is MDCG 2019-16, so start here. The guidance is not specifically on intended purpose, but it is on classification for IVDs and it talks about intended purpose, how to establish it, the impact to your classification.



As a regulatory director, what IVDR transition milestones would you set for the end of 2020?

In the initial IVDR audit, they will be looking at your entire Quality Management System, so you must make sure that your QMS is almost done. Also, have your product submission cadence sorted by going through products and sorting them by priority, especially understanding what your high-risk products are so there are no surprises. You should also have your contract signed with your notified body, all your devices classified, and your audit on the schedule. Lastly, have your PRRC identified.



How do you determine what is considered sufficient clinical evidence for an IVD to satisfy NB?

There is no set number, and it depends on the risk of the IVD. You must tell your story and address the data you generate pre-market and the data you generate post-market. This includes items such as complaints, vigilance, and post-market performance follow-up activities.



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