Medical Device and In Vitro Diagnostics Regulatory Consulting Services
Consulting Services Medical Device and In Vitro Diagnostics
Partner with Qserve to access the expertise and support needed to achieve your regulatory and market approval objectives. Contact us to learn about our consulting services and discover how we can help you attain global market access.
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Medical Device and In Vitro Diagnostics Regulatory Consulting Services
Medical Device Regulatory Consulting Services
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:
- Compliance and Needs Assessment
- Regulatory and Clinical Strategy
- US FDA submissions support for PMA, pre-submission, and DeNovo 510(k)
- Due Diligence
- GAP Analysis
- Submission file/ documentation
- Market Approval
- Notified Body Like Review
- Quality Management
- Local Representation
- Ad hoc and Interim Support
- Startups
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
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
- Our IVD Consulting services
- Design and development process
- Companion diagnostics services
- Due Diligence
- Ad hoc and interim support
- IVDR Training
Regulatory, quality and market access support around the world
- US FDA submissions support for PMA, pre-submission, and DeNovo 510(k)
- EU IVDR services
- IVDR extension to transition timelines
- From IVDD to IVDR support
- CE mark IVD support
- Notified Body support
- Post-market surveillance, PMPF and vigilance
- Local representation
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
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:
- Clinical Strategy
- PMA/IDE annual reports
- GAP analyze
- Clinical Evaluation
- CEP/ CER for Medical Devices
- PEP/CPR/ SVR/ APR for In Vitro Diagnostics
- State of the Art / Standard of Care
- Ad hoc support
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
Medical Device Registration
Introducing your medical devices into target markets demands careful consideration of numerous critical factors. From identifying the most promising markets for device registration to navigating the terrain of regulatory compliance, international product safety, performance testing, and certification.
Our Global Registration services:
- Market access strategy | Go-to-market roadmap
By collaborating with our global team of experts, you gain valuable insights into international regulations. We understand the pathways for market access, ensuring a smooth journey for your products into the global marketplace. - Medical Device Registration Services:
Countries in Europe:
Europe | CE marking medical devices | CE marking IVDR
UK | UKCA medical devices and IVDsCountries in America:
United States| FDA medical device registration and IVDs
Canada| Health Canada registrationCountries in Latin America:
Brazil| Anvisa registration Colombia| Colombia registration
Mexico | Cofepris registrationCountries in Asia-Pacific:
China | NMPA registration
India | India registration
Malaysia | Malaysia registration
Thailand| Thailand registration
Singapore | HSA registration
South Korea | Medical device registration
Countries in Oceania:
Australia| TGA registration
New Zealand | WAND registration
Countries in the Middle East:
Saudi Arabia | SFDA registrationOther countries: Contact us
for more information on worldwide medical devices and IVD registration. Together, we address the common basic set of essential requirements applicable in every country while also ensuring compliance with specific international regulations to uphold product quality and safety standards.
- Local Representation
- EUDAMED
- UDI
Plan a free introductory call
CRO Clinical Studies
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:
- Study Strategy
- Clinical Study Design
- Study Startup
- Clinical Study Documentation
- Study Management
- Safety & Data Management
- Analyses & Report
- Good Clinical Practice (ISO14155)
- Ad hoc support
- Interim Support
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
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
We specialize in delivering quality 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 experts brings extensive experience and expertise in quality management systems, regulatory requirements, and industry best practices. Whether you need strategic guidance, gap analysis, or support with specific quality standards, we have the knowledge and resources to assist you every step of the way.
Our Services:
- Strategy
- Gap analysis
- QMS (FDA, QRS, 20CFA820, ISO13485 and ISO14155)
- Quality standards (company and product standards)
- Risk Management ISO14971
- PRRC
- Ad hoc & interim support
- MDSAP support
- Compliant 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
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
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:
- MDR Suite
- IVD Suite
- Clinical Suite
- FDA 510 (k) Submission
- FDA Premarket approval
- NMPA China basic training
- PRRC
- QMS/ ISO13485
- MDSAP
- Introduction to Risk Management (ISO 14971)
- Advanced Risk Management
- SaMD
- Eudamed
- UDI (Global)
- ISO14155/GCP
- All training courses
Learn more about our training offerings and discover how Qserve can help elevate your team's capabilities and expertise.
Plan a free Introductory call
