US Market Access

Expert FDA Consulting Solutions for Medical Device and IVD Manufacturers

Unlocking Innovation Through Expert FDA Consultancy

Navigating the ever-changing landscape of the United States Food & Drug Administration can be daunting - that's why Qserve is your global MedTech partner. Our consultants specialize in US market access with a focus on FDA submissions including 510(k), PMA, pre-subs, and De Novo requests.

Whether you're initiating a new project or navigating complex regulatory terrain, our comprehensive solutions empower your success by providing practical, risk-based guidance and unwavering support.

Qserve specializes in:

  • Streamlining 510(k) clearance
  • Optimizing pre-submission interactions
  • Guiding De Novo requests
  • Navigating Breakthrough Designations
  • Supporting IDE applications
  • Strategically securing PMA approvals

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Navigate the complexities of your 510(k) submission with our comprehensive FDA whitepaper on the post-510(k) process.
Written by Qserve FDA expert Michelle Hasse, this essential guide delves into the critical steps following your 510(k) submission, offering invaluable insights into effective communication with the FDA, post-submission assessments, and strategies for addressing
potential challenges.

Download Now

Comprehensive Services to Navigate US Market Access

Our team of FDA consultants is equipped to offer a wide range of market access and compliance services for medical devices and in vitro diagnostics. Additionally, our subject matter experts are readily available to address technical questions about FDA requirements for software/cybersecurity, electrical safety and electromagnetic compatibility, biocompatibility, and sterilization/shelf-life.

FDA Regulatory Strategy

Our expert FDA consultants will work closely with your team to develop a robust and tailored regulatory strategy for your medical device or IVD. We consider your product's characteristics, intended use, target market, and risk profile to create a roadmap for successful FDA submissions while meeting business goals.

  • FDA regulatory pathways and strategic approach 
  • Global market access strategies with particular focus of US and European Economic Area (EEA)
  • Merger & acquisition due diligence and acquisition integration
  • Regulatory consulting throughout product development 
    • Design & development 
    • Risk management 
    • Software development
    • Cybersecurity and interoperability  
    • Electrical safety and electromagnetic compatibility  
    • Biocompatibility 
    • Usability 
    • Sterilization, packaging, and shelf-life 
    • Preclinical studies 
    • IVD analytical studies, IVD performance studies, and Point of Care (POC) considerations
    • Clinical studies for FDA submissions
    • Manufacturing quality engineering

Schedule your free introductory call today to get started.

FDA Submission Support

Whether it's 510(k) or PMA submissions, our FDA consultants will expertly guide you through the entire submission process. We meticulously review your technical documentation, offer strategic feedback, and skillfully draft the submission, ensuring all essential requirements are meticulously met. 

  • 510(k) submissions (premarket notification)
  • PMA submissions (premarket approval)
  • De novo requests
  • Pre-submissions
  • Investigational Device Exemptions (IDE)
  • Breakthrough Device Designation Requests
  • Safer Technologies Program (SteP) Entrance Requests
  • Emergency Use Authorizations (EUA)
  • Humanitarian Device Exemptions (HDE)
  • Predetermined Change Control Plans (PCCP)
  • CLIA Waiver Applications 
Schedule your free introductory call today to get started.

FDA Compliant QMS Implementation

Strategically build or adapt your QMS to meet FDA regulations with Qserve's FDA consultants. Whether you are establishing a new QMS or modifying an existing one to meet FDA requirements, our focus on efficiency and harmonization across different markets ensures compliance without unnecessary complexity, setting the foundation for long-term success in the competitive medical device and IVD industry. 

  • Tailored Quality Management System Implementation 
  • Representation at FDA inspections 
  • MDSAP implementation 
  • FDA QSIT style mock inspections 
  • QMS resource support 
  • Internal audits 
  • Supplier controls program 
  • QMS gap assessment to 21 CFR 820 
  • Training and education programs 
Schedule your free introductory call today to get started.

 US Post-Market Compliance and Support

Our services extend beyond initial market access. Qserve provides post-market compliance support, including post-market surveillance, adverse event reporting, labeling and promotional material review, compliance with post-market studies and requirements, and overall post-market support to ensure ongoing regulatory compliance. 

  • Post-market surveillance 
  • Adverse event reporting/Medical Device Reporting (MDR) 
  • Labeling and promotional material/website review 
  • Design change assessments for regulatory impact
  • Compliance with post-market studies and requirements 
  • FDA US Agent services 
  • Establishment registrations and device listing 
  • UDI and GUDID support 

Schedule your free introductory call today to get started.

FDA Compliance Assessments and Remediation 

If you encounter regulatory challenges or receive FDA inspection findings (483s), our team will collaborate with you to identify areas for improvement. We'll develop effective strategies for remediation, helping you achieve market access quickly and efficiently. 
  • CAPA resolution 
  • Recall management 
  • Request for additional information (AINN letter)
  • 483s/warning letters 
Schedule your free introductory call today to get started.

Why choose Qserve for FDA consulting?

Tailored Regulatory Solutions: At Qserve, we understand that each product and company is unique. Our FDA consulting services are customized to meet your specific needs, product objectives, and market access strategy. We work closely with you to develop a regulatory strategy that aligns with your business goals. 
Unparalleled FDA Experience: Our expert FDA consultants possess extensive experience in dealing with FDA regulations, submissions, and inspections. We stay up-to-date with the latest FDA guidance and requirements, ensuring your FDA submissions are accurate and compliant. 
Practical Approach: We pride ourselves on offering practical, risk-based solutions that balance regulatory compliance with your business objectives. Our FDA consultants focus on efficiency and effectiveness, ensuring that you achieve your market access and submission goals without unnecessary delays. 
Global Perspective: Qserve operates internationally, providing a global perspective on regulatory requirements. Whether you're targeting the US market or seeking approvals in multiple regions, our consultants can guide you through the complexities of global regulations. 

Qserve: Your Trusted Navigator for US Market Entry and Regulatory Compliance

At Qserve, we are dedicated to helping you achieve FDA compliance and market success. Whether you need assistance with FDA submissions, QMS implementation, or compliance assessments, our expert FDA consultants are here to support you every step of the way. Take the first step towards regulatory success. Contact us today to discuss your FDA consulting needs and unlock the potential of your medical device or IVD in the global market. 


Schedule a free introductory call

Featured US FDA Consulting Services

FDA Pre-Submissions

FDA pre-submissions, also known as pre-sub or pre-IDE (Investigational Device Exemption) meetings, are voluntary interactions between manufacturers and FDA. These meetings allow developers to seek feedback and guidance from the FDA regarding their product's regulatory pathway, clinical trial design, and other related topics before submitting a formal application.

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510(k) Submissions

A 510(k) is a premarket submission to the FDA for certain medical devices. It demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness before it can be marketed and sold in the United States.

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US FDA Agent

Medical device and IVD manufacturers are required to register their establishment and notify the FDA of their intention to market their medical devices. Additionally, manufacturers located outside the United States must appoint a US FDA Agent to act as their intermediary with the FDA.

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