RQMIS is happy to announce the posting of our new blog titled "Unlocking the Path to Medical Device Insurance Reimbursement" Dive into our new blog to discover how RQMIS can help you unlock the path to effective insurance reimbursement. https://lnkd.in/e7XMMX5t #MedicalDevices #InsuranceReimbursement #Healthcare #MedTech #RQMIS #RegulatoryAffairs
RQMIS
Business Consulting and Services
Amesbury, MA 1,132 followers
We integrate Regulatory, Clinical and Quality requirements with medical product lifecycle success.
About us
Our vision is simple: To be the provider of choice for the development and implementation of regulatory and insurance strategy by utilizing the most efficient and effective commercialization pathway to medical product markets across the globe, including designing the quality system that brings the product to life. When these pathways demand clinical evidence to validate that a product is safe and effective, whether it is for publication, insurance reimbursement or regulatory approval, RQMIS provides our customers with complete support for the entire product lifecycle. Since 1996, RQMIS has been providing manufacturers in the medical and healthcare industries with strategic guidance on how to effectively navigate the FDA and EU regulations. Our consultancy is focused primarily in four areas: Regulatory Strategy and Submissions, Clinical Study Design and Management, Quality Systems Design and Compliance, and Insurance Reimbursement. Our headquarters is located in Boston, MA and we have two additional locations in London and Barcelona.
- Website
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http://www.RQMIS.com
External link for RQMIS
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Amesbury, MA
- Type
- Privately Held
- Founded
- 1996
- Specialties
- Medical Devices, Regulatory, Clinical, Consulting, Quality Management Systems, 510(k), FDA Clearance, EU MDR / IVDR, Clinical Trial Design, EU Authorized Representative, US Agent, Audits, FDA Presubmission, Techincal Files, Clinical Evaluation Report (CER), Regulatory Strategy, Product Classification, Insurance Reimbursement, Post-Market Surveillence, UK Responsible Person, De Novo, and FDA Consulting
Locations
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Primary
Get directions
110 Haverhill Road
Suite 526
Amesbury, MA 01913, US
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Get directions
4 Whitan Way
Witney, Oxfordshire OX28 6FF, GB
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Get directions
Av. Diagonal 409 - 1st Floor
Barcelona, Catalunya CP: 08008, ES
Employees at RQMIS
Updates
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RQMIS is proud to announce the release of our latest blog on "Achieving Breakthrough Classification" We have successfully helped several of our clients receive their Breakthrough Classification, and we wanted to share how we helped get their groundbreaking products to market faster/ https://lnkd.in/eHvc3VwM #MedicalDevices #HealthcareInnovation #RegulatoryAffairs #BreakthroughClassification #RQMIS #Innovation #Healthcare
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We are excited to share our latest blog post, "Understanding the Role of the United Kingdom Responsible Person and the Process for Obtaining a UKCA Mark for a Medical Product." Navigating regulatory compliance in the UK can be complex, especially with the evolving requirements for medical products. Whether you're a medical device manufacturer or a regulatory affairs professional, this comprehensive guide provides valuable information to help you succeed in the UK market. https://lnkd.in/e_nBac2A #UKCA #MedicalDevices #RegulatoryCompliance #UKResponsiblePerson #MedicalProduct #HealthcareIndustry
Understanding the role of the United Kingdom Responsible Person (UKRP) and the Process for UKCA Marking (UKCA) for Medical Products
rqmis.com
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RQMIS is thrilled to announce the launch of our new blog, which focuses on demystifying the EUAR (European Union Authorized Representative) and CE Marking processes! Navigating the complexities of regulatory compliance in the EU can be challenging, but our blog is here to help. Whether you're a seasoned professional or new to the world of EU regulations, our blog aims to provide valuable information and practical advice to help you succeed. Check out our latest posts and stay informed about the latest developments in EU compliance. Follow our blog and never miss an update! https://lnkd.in/epAGpF-e Feel free to share your thoughts and questions in the comments below. We look forward to engaging with you and supporting your journey to compliance! #EUMarking #CECompliance #EURegulations #ProductCompliance #EUAR #BusinessGrowth #RegulatoryCompliance
Understanding the role of the European Union Authorized Representative and the Process for CE Marking for Medical Products
rqmis.com
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Are you developing a new drug, medical device, or combination product? Understanding the FDA clearance process is crucial to bringing your innovations to market safely and effectively. In our latest blog post, we demystify the FDA clearance pathway, providing a comprehensive guide on the key steps and considerations for medical product developers. Read the full post here: https://lnkd.in/gywzZ7MN #FDA #MedicalProducts #RegulatoryAffairs #DrugDevelopment #MedicalDevices #Biologics #HealthcareInnovation #QualitySystems #Pharmaceuticals #Biotechnology
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At RQMIS, we are committed to providing top-tier support for your regulatory, clinical, quality, insurance reimbursement, and cybersecurity needs. Our expert team brings decades of experience to help you navigate the complex landscape of medical device and pharmaceutical industries. 🔹 Regulatory Services: From FDA submissions to CE marking, we ensure your products meet all regulatory requirements seamlessly. 🔹 Clinical Services: Our clinical research expertise spans study design, management, and monitoring to ensure robust and reliable data. 🔹 Quality Assurance: We help you maintain the highest quality standards, ensuring compliance with ISO, FDA, and other regulatory bodies. 🔹 Insurance Reimbursement: Navigating the reimbursement landscape can be challenging. Our team provides strategic guidance to optimize your reimbursement pathways. 🔹 Cybersecurity: In today’s digital age, safeguarding your data is paramount. Our cybersecurity services are designed to protect your sensitive information and ensure compliance with the latest regulations. Partner with RQMIS to streamline your processes, reduce time to market, and achieve commercial success. Let’s work together to bring innovative and safe medical solutions to patients worldwide! Contact us today to learn more about how RQMIS can support your business goals. #RegulatoryAffairs #ClinicalResearch #QualityAssurance #InsuranceReimbursement #Cybersecurity #MedicalDevices #Pharmaceuticals #RQMIS
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See how RQMIS assisted the US Army Medical Research and Development Command gained FDA clearance for their APPRAISE-HRI software application operating on a smart phone to effectively triage internal hemorrhaging to save patient lives. https://lnkd.in/eDDJWYAc #mtec #regulatorycompliance #medicalproducts #healthcareinnovation #cybersecurity #regulatoryaffairs
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RQMIS provides comprehensive regulatory, quality cybersecurity, and clinical consulting to the global medical device, pharmaceutical, nutraceutical and cosmetic industries. #medicaldevice #medicaldevices #regulatory #cybersecurity #FDAapprovedProduct
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