Even when focused on a specific function, we always look at the big picture and prioritize your business goals. We deliver solutions that not only meet the specific objectives of the task at hand but also optimize processes and improve efficiency.
Trusting a partner to take on key regulatory and quality functions can be a concern, especially for critical tasks that require specialized expertise.
RQM+ holds strong experience in providing services on a managed outsource basis, partnering with our clients to achieve business objectives.
Although certain tasks—such as complaint management, retrospective PMCF/PMPF studies, and CERs/PERs—are necessary for maintaining compliance, they do not necessarily contribute to your larger business goals. By allowing RQM+ to manage these types of functions, you can free up valuable internal resources to focus on the future.
No matter how many products you sell or what class they are, the experienced team at RQM+ has done it all. With former regulators and notified body leadership on staff, we know how to help you maintain compliance—even with the new EU MDR and IVDR regulations.
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 regulators on our team, we know what reviewers look for. This allows us to draft submissions that generate fewer questions and helps get your products to market faster.
The new EU regulations require ongoing post-market clinical and performance studies, and many manufacturers are struggling to figure out how they will execute this mandate. Clinical and technical expertise is required to design meaningful studies, deploy them, and compile the data so they will be acceptable to notified bodies in your PMCF report. RQM+ has the experience and expertise (including former NB leadership), client-validated processes, and tools to conduct studies effectively with a nearly turnkey approach.
The work isn’t done after a product has been approved and on the market. RQM+ can handle clinical regulatory affairs for entire product lines or therapeutic categories so you can be confident that your clinical and performance evaluation reports (CERs and PERs), periodic safety update reports (PSURs), and other required documentation are always submitted on time to maintain compliance with minimal burden on your team.
Audits are extremely time consuming, especially if you operate in multiple markets and have suppliers around the world. Shifting attention to audits can have a negative impact on other important quality management tasks, especially if a significant portion of your audit team are resources that belong to other departments. RQM+ can provide dedicated global auditing services that will improve the efficiency and effectiveness of your audit program, while allowing your team to concentrate on essential processes.
The organizational expertise of a manufacturer is often focused on product development and proactive risk management in an effort to avoid complaints. Unfortunately, though, complaints will happen—and typically, more than expected. Although complaint handling is a critical function for post-market surveillance, it can be a burden on internal teams and detract from the work required to meet business objectives. RQM+ can handle it all for you and ensure that the complaint handling process integrates seamlessly with other post-market surveillance systems.
With complete managed outsourcing, you get a strategic partner that works with the best interest of your business in mind and seasoned experts who deliver added value.
Our solutions provide a dedicated team of resources that handle more than just the technical tasks—you’ll have project management, resource management, and technical leadership like you’ve never had before.
With RQM+ managed outsourcing, we handle everything for you so your team has a single point of contact and only one partner with specific deliverables.
We are laser-focused on providing quality service that exceeds expectations and improves your business—and we have the experience to deliver on this promise.
RQM+ is dedicated to the medical device and diagnostic industries, and has expert resources across all clinical specialties and device classes to support all of your products.
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