Medical device and IVD consulting services

Consulting for medical device and IVD market access

Medical Device and In Vitro Diagnostics Regulatory Consulting Services

Consulting Services Medical Device and In Vitro Diagnostics

Medical Device Regulatory Consulting Services 

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We specialize in providing comprehensive solutions tailored to meet the unique needs of the medical device industry. We understand the landscape of medical device development and regulation. Our team of experts brings years of experience and expertise to the table, guiding you through every stage of the product lifecycle, from concept to commercialization.

We offer a diverse range of consulting services designed to address your specific challenges and maximize your opportunities in the dynamic healthcare market. Whether you're navigating regulatory compliance, optimizing product design, or streamlining manufacturing processes, we have the knowledge and resources to help you succeed.

Our services:

Learn more about our medical device consulting services and discover how we can help you achieve your objectives.

Schedule a free Introductory call

In Vitro Diagnostics Consulting Services

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As the landscape of healthcare continues to evolve, the demand for accurate and reliable diagnostic solutions has never been greater. At Qserve, we recognize the unique challenges and opportunities inherent in the field of IVD. While IVDs share similarities with medical devices in many aspects, they also possess distinct regulatory requirements and complexities.

Our global team of IVD regulatory consulting specialists is dedicated to helping you navigate this landscape with precision and confidence. We offer tailored services across the product life cycle to support the final IVD device and CDx. Qserve addresses the unique needs of IVD and CDx implementation, ensuring compliance, efficiency, and effectiveness every step of the way.

Compliance and Needs Assessment including GAP Analysis and strategy

Regulatory, quality and market access support around the world

Whether you're seeking guidance on regulatory compliance, product development strategies, quality management systems, or market access requirements, we have the expertise and experience to support you.

Schedule a free Introductory call

Medical Writing Services

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As the healthcare industry continues to evolve, the demand for accurate and compliant medical documentation has become paramount. At Qserve, we understand the critical role that effective medical writing plays in the success of medical device development and regulatory compliance.

Our team of Medical Writers brings a unique blend of expertise in medical writing and regulatory affairs, offering you unparalleled insights and support throughout your product lifecycle. With a deep understanding of regulatory requirements and industry standards, we ensure that your medical device documentation not only meets but exceeds expectations.

From writing and reviewing technical documents such as regulatory submissions, clinical evaluation reports, and annual reports, our team is dedicated to delivering high-quality, compliant content that reflects the integrity and innovation of your products.

Our Medical Writing services:

Learn more about our comprehensive suite of medical writing services and discover how we can support your goals and objectives.

Plan a free Introductory call

CRO Clinical Studies

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We offer a full spectrum of solutions to support your clinical study needs, from study strategy and design to study management and beyond.

Our dedicated team is committed to helping you navigate every aspect of the clinical study lifecycle with expertise and precision. Whether you need study startup support, clinical study documentation, or safety and data management solutions, we have the knowledge and resources to guide you every step of the way.

Our services: 

Learn more about how we can support your clinical studies

Plan a free introductory call

Post Market Activity (PMCF) Services  

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we offer a range of Post Market Clinical Follow-up (PMCF) services designed to support medical device and in-vitro diagnostic companies in their post-market surveillance and compliance efforts.

At Qserve, we recognize the importance of post-market activities in ensuring the ongoing safety and effectiveness of medical devices and in-vitro diagnostics. Our team of experts is dedicated to helping clients navigate the complexities of post-market surveillance by designing and implementing PMCF surveys and studies that gather real-world data on product performance and safety.

With our deep understanding of regulatory requirements and industry best practices, we work closely with our clients to develop PMCF strategies that are both robust and efficient. From study design and protocol development to data collection, analysis, and reporting, we offer a practical approach to help clients achieve their post-market objectives effectively and efficiently.

Our services: 

  • Post-market surveillance Plan
  • PMCF for medical devices
  • PMPF for In Vitro Diagnostics
  • PMSR
  • PSUR
  • Recall
  • Vigilance
  • Ad hoc and Interim support

Explore our range of PMCF services and discover how we can help you navigate the complex landscape of post-market surveillance with a practical approach.

Plan a free introductory call

PMCF Survey

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At Qserve, we understand the critical importance of post-market activities in ensuring the ongoing safety and effectiveness of medical devices and in-vitro diagnostics.

Our dedicated team specializes in offering tailored PMCF Survey services to assist medical device and in-vitro diagnostic companies in gathering real-world data on product performance and safety. We provide end-to-end support throughout the entire survey process, from planning and conduct to analysis and reporting.

Our services: 
  • PMCF Survey Plan
  • Survey & Conduct
  • Analysis & Report

Learn more about our Post-Market Survey solutions and discover how we can help you navigate the complex landscape of post-market surveillance with a practical approach.

Plan a free Introductory call

Quality Assurance for Medical Devices and IVDs

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Quality Assurance (QA) in medical devices is a systematic and comprehensive approach to ensuring the safety, performance, efficacy, and reliability of (In Vitro Diagnostic) medical devices throughout their entire lifecycle. The primary goal of QA is to guarantee that medical devices meet (quality) standards and applicable regulatory requirements to safeguard patient health and well-being.

QA is crucial not only for meeting legal requirements but also for establishing trust among manufacturers, supply chain operators, healthcare providers, users, and patients. It ensures that (IVD) medical devices perform reliably under expected conditions, thereby reducing the risk of failures that could lead to serious health consequences. In addition, a robust QA approach promotes the quality culture within organizations and encourages continuous improvement. Critical elements of QA include an established Quality Management System (QMS), which addresses critical processes such as quality management, management responsibility, design control, risk management, production and service control, nonconformance handling, CAPA, and post-market activities including complaint handling.

We specialize in delivering quality assurance services tailored to meet the diverse needs of the medical device and in-vitro diagnostic industries. We offer a comprehensive suite of services designed to elevate the quality standards of your organization and products.

Our team of quality assurance experts brings extensive experience and expertise in (Quality) Management Systems, standards such as ISO 9001, ISO 13485, and ISO 27001, and regulations including EU MDR/IVDR, 21 CFR 820 Q(M)SR, MDSAP jurisdictional requirements, and industry best practices. Whether you need strategic guidance, gap assessment, or support with the implementation of specific standards, we have the knowledge and resources to assist you every step of the way.

Our Services:

  • Quality Planning
  • Quality Management System (QMS) Gap Assessment and Implementation
  •  Ad Hoc & Interim QA/RA Support
  • MDSAP Support
  • Post Market Surveillance (PMS), Complaint Handling, and CAPA Support

We are dedicated to helping you achieve and maintain the highest standards of quality and regulatory compliance.

Plan your free introductory call

 

Auditing Services

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At Qserve, we understand the critical importance of auditing in maintaining the highest standards of quality, safety, and compliance. Our goal is to empower organizations with the insights and tools needed to achieve excellence and drive continuous improvement.

Our Services: 

  • Internal Audit
  • Supplier Audit
  • FDA Audit
  • Mock Audit
  • NMPA Audit

Learn more about our Auditing Services and discover how we can support your organization in meeting its regulatory and quality objectives.

Plan a free introductory call

MedTech Training

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At Qserve, we understand the importance of continuous learning and development in navigating the complex landscape of regulatory, quality, and clinical requirements.

Our dedicated team of experts brings years of international experience and specialized expertise to the table, offering training programs designed to empower medical device manufacturers at all levels. Whether you're seeking regulatory guidance, quality management insights, or clinical expertise, we have the knowledge and resources to support your training needs.

Our training offerings include:

Learn more about our training offerings and discover how Qserve can help elevate your team's capabilities and expertise.

Plan a free Introductory call

Startup Services 

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Embarking on the journey of bringing a medical device to market is both thrilling and complex. At Qserve, we specialize in providing tailored services to startups within the medical device industry, ensuring your success every step of the way. Our team is dedicated to supporting you in defining a regulatory and clinical strategy that aligns perfectly with your product and goals. 

Our services:

Learn more about our startup services and discover how we can help you achieve your objectives.

Schedule a free Introductory call

Learn How Qserve can Benefit Your Company

At Qserve, we understand the unique challenges and opportunities that companies of all sizes face in the medical device and IVD industries. Our goal is to support you in navigating the regulatory landscape with a practical approach, bringing your products to market successfully.

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How we work 

Qserve is your dedicated partner for Consulting Services in the Medical Device and In-Vitro Diagnostic (IVD) industries globally. Whether you're a startup, small or mid-size company, or a multinational corporation, we're here to support you in bringing your products to the global market.

At Qserve, we work with a global team of experts, managing various projects across the medical device and IVD landscape. We collaborate to navigate the complexities of regulatory compliance and market approval processes, ensuring your products meet the requirements for successful market entry.

Are you seeking a partner to assist you in preparing your product for Market Approval? Look no further. Our compliance services include:

Regulatory Strategy

 We provide strategic guidance to help you develop a roadmap for regulatory compliance and market access tailored to your specific product and target markets.

Quality Management System (QMS) Compliance: 

We help you establish, implement, and maintain robust QMS systems aligned with international standards and regulatory requirements.

Device Registration 

Our experts assist with preparing and submitting regulatory applications for device registration, streamlining the process, and expediting market entry.

In-Country Regulatory Representation

Our global network of regulatory experts offers in-country representation services, ensuring compliance with local regulations and facilitating communication with regulatory authorities.

Full-service Medical Device CRO 

From designing and executing clinical trials to conducting PMCF surveys, we offer a comprehensive suite of services tailored to meet your medical device and IVD needs.