RQM+ solution value prop in context of specific role, vertical market or a specific challenge.
EU MDR has forced manufacturers to rethink their current regulatory practices, internal methodologies, and ongoing level of compliance investment. Our transformative solutions were developed specifically to navigate the intricacies of today’s regulatory environment, including the necessary shift in compliance strategies from risk-based necessity to value-driven solution.
We know how challenging it is to give equal attention to every product in your portfolio, especially when internal resources are strained. From portfolio planning to project management to executing discrete regulatory tasks, RQM+ helps you develop and implement risk-balanced strategies that are tailored to your business goals.
One of our greatest advantages is our ability to recruit former notified body leadership, including experts who have participated in committees and contributed to the content of standards and guidance documents. With this knowledge base—plus our deep commitment to ongoing learning through systemized processes—we bring a level of expertise that other consultants cannot match.
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The EU MDR was published in the Official Journal of the European Union on 5 May 2017, and entered into force on 26 May 2017.
The EU MDR was published in the Official Journal of the European Union on 5 May 2017, and entered into force on 26 May 2017.
All medical devices and related procedures, systems, and documentation in the EU must comply with the new MDR by this date in order to enter the market.
All medical devices and related procedures, systems, and documentation in the EU must comply with the new MDR by this date in order to enter the market. Certificates issued under the MDD before this date may remain valid for up to three additional years.
If you make a significant change to your MDD certified device, you will be required to obtain MDR certification.
All devices, whether MDD or MDR certified, must have EU MDR PMS, Vigilance, and Market Surveillance on the date of application. Registration via ACTOR module of EUDAMED strongly encouraged.
Any unexpired notified body certificates issued under MDD will become void on this date. All devices placed on the market must conform to EU MDR.
Any unexpired notified body certificates issued under MDD will become void on this date. All devices placed on the market must conform to EU MDR.
Sell-through provision starts for MDD devices already on the market. Class I devices that require a notified body must be compliant with EU MDR.
Our new series of interactive tools allow you to easily filter lines of the IVDR and MDR by topic, chapter, section, article, and any search term. Many of our experts have this tool open at all times on their computers for quick access and it's been a game changer. Now we're sharing them with you!
We will provide a team that has a single focus on MDR implementation and continual alignment with your business. RQM+ ensures project goals and deadlines are met with steering teams, stage gate reviews, and workstream owners so that every aspect of MDR is covered. This approach allows your team to focus on current activities while maintaining alignment and control of EU MDR implementation.
We provide a customized strategy by product line and portfolio planning support that balances regulatory risks with business goals. This includes gap analyses by product family; product realignment in MDR technical documentation files; and gap closure with product development, manufacturing, post-market surveillance, and clinical teams. We also provide strategy and responses to notified body audit findings, including negotiation, based on recommendations from former notified body leaders and SMEs on staff.
Design quality engineers provide gap analyses of design history files and full remediation or SME guidance to client teams as needed to achieve compliance. RQM+ can offer support across all impacted areas, including risk management, standards compliance, supplier quality, clinical evaluations, biocompatibility, hazardous substances, labeling, and manufacturing. We also provide strategies for demonstrating compliance of legacy products to updated standards including rationales and justifications where possible.
When you need to prepare your quality management system (QMS) for the transition to MDR, our expert team can develop the quality plan and help you implement it. We provide comprehensive QMS gap assessments, quality system leadership, and implementation of QMS updates for MDR compliance. Certified biomedical auditors perform internal and mock NB audits and supplier and economic operator audits to ensure compliance.
MDR requirements have significantly increased post-market surveillance (PMS) deliverables, and many manufacturers are struggling to allocate the necessary resources. RQM+ has extensive thought leadership and expertise in creating PMS and PMCF plans and periodic safety update reports (PSURs) along with developing and executing retrospective PMCF studies. Our integrated approach ensures consistency between PMS, CERs, and risk management documentation.
We do more than add capacity to your team. We add value to your business. When you need a strategic partner to support MDR implementation, RQM+ has it all: experience, expertise, thought leadership, and unique industry insights.
Your internal team might be new to MDR, but our project managers and SMEs have implemented the current regulations from start to finish.
Our interactions and feedback from multiple notified bodies—including BSI, TÜV SÜD, and GMED—have allowed us to develop best practices for every type of product.
We have created hundreds of technical documentation files for 70+ clients across all device classes, and we refine and improve our processes with every submission.
Our team members have participated on committees, drafted MDCG guidance documents, created MDR interpretations, and trained notified body teams. We understand notified body expectations.
Outsourcing can feel like you are losing control over important support functions with increasing reliance on a third party—but not with RQM+. We act as a strategic partner that integrates fully with your team and adds value to your business through transformative solutions.
Compared to the MDD, the MDR does require more substantial evidence when a product is equivalent which manufacturers are finding a bit harder to achieve. The MDR requires technical, biological, and clinical characteristics that are shared equivalence to another device that you’ll want to consider.
Compared to the MDD, the MDR does require more substantial evidence when a product is equivalent which manufacturers are finding a bit harder to achieve. The MDR requires technical, biological, and clinical characteristics that are shared equivalence to another device that you’ll want to consider.
Although it is difficult to give a specific timeline, BSI is doing three rounds of questions and your response to the questions will play into the timeline of the overall review. We have heard as little as six months, however, we have experienced much closer to 12 months.
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