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Designed for You. Always.
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Full Service
Our Full Service model is the gold standard for clients seeking a robust support system for EU MDR and IVDR clinical regulatory affairs challenges and is the best model for most clients. It offers comprehensive project management, strategic guidance, and an individual or team of technical experts.
Ideal for clients who require:
– In-depth project management
– Strategic insights
– Collaborative team approach
– Support for complex regulatory situations -
Value+
With Value+, experience a streamlined yet powerful approach to creating EU MDR and IVDR clinical affairs documents. Offering senior-level expertise at 30% less cost than our Full Service model, Value+ is ideal for clients who need:
– High-quality, cost-efficient documents
– Senior-level expertise without additional subject matter expert and project management support
– Solutions for straightforward regulatory needsClients who meet the following criteria are typically a great fit for Value+:
– Have a limited budget
– Just want a document and a writer
– Have final input documents available
– Able to commit to an efficient timelineWe offer this service for document updates, as well as new documents.
Clinical Roadmap
Our experts will help you develop a clinical evaluation strategy to achieve your business objectives and notified body approval.
We provide innovative strategies for using existing data along with your PMCF plan based upon our experience with a wide range of notified bodies.
From CEPs to SSCPs, we enable you to tell a compelling story, making your documentation appealing to regulators.
Our integrated approach reduces time to certification with fewer notified body questions and nonconformities.
Quality System Solutions
CERs cannot be created in a bubble by the clinical team. There are inputs and outputs between clinical, post-market surveillance, and risk management. Integrating the processes optimizes resources and reduces the risk of audit findings. Our experts will help you update and revise your quality system so that all your processes are working together efficiently. This will ensure that you can meet the requirements of the MDR now and in the future.
NB Response Support
The notified body may not interpret the MDR's requirements in the same way you do and you only have three rounds of Q&A to gain alignment and approval. Additionally, a deficiency that calls for more clinical data could result in an expensive study or the loss of product certification. With so much on the line, a different perspective and proposed response plan from our former notified body leaders and subject matter experts could make all the difference.
CER Remediation
The RQM+ team will assess your CER process and documentation by product line, providing you with a detailed gap analysis and remediation plan. Our team of experts can effectively execute a remediation of any size, minimizing the burden on your team so you can maintain focus on new products.
Our CER project managers act as the single point of contact for all client needs and are responsible for leading meetings, developing schedules for deliverables, monitoring progress, and driving results. This includes actively managing the client approval process and coordinating independent review of all documentation.
For ongoing compliance, we ensure client documentation is updated as new data becomes available and then provided to notified bodies by the required deadlines.
Featured Leader
Amie Smirthwaite, Ph.D.
Senior VP, Intelligence & Innovation
Dr. Amie Smirthwaite joined RQM+ in March of 2020. A clinical and regulatory affairs expert, Amie has over 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading the RQM+ Intelligence and Innovation team and brings a wealth of knowledge and experience having worked for medical device companies, academic institutions, and BSI.Entrusting your CERs to a consulting firm requires confidence in the team. With RQM+, you get a level of clinical and regulatory expertise and client dedication you won’t find anywhere else.
Tap into the RQM+ Knowledge Center
RAPS + RQM+ Webcast —PMCF User Feedback Surveys
How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR
PMCF Under MDR
The integration of clinical, regulatory, risk management and post market surveillance is a difficult and confusing task. How should the data flow and where does it start?
Best Practices in Scientific Database Searching
Best Practices for Integrating CERs and PMS Under MDR
We are passionate about your success. Tell us more about your needs so we can help.
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