Dossier Submission Support
We help you create your submission files, knowing which requirements need to be met. First time right!
Gain regulatory clarity early
Creating your technical documentation for submission can be challenging, due to complexity of regulatory frameworks across different markets. Regulations such as the EU Medical Device Regulation (MDR), the US FDA’s 510(k) or PMA pathways, and China’s NMPA requirements each demand different structures, standards, and submission formats. Do you create your submission files out of your Design history file?
Extensive documentation and data are needed for each compliant submission. Technical documentation for an EU MDR submission must include:
- Device description and specifications
- Complete set of labelling and IFUs
- Design and manufacturing information
- Demonstration of how the general safety and performance criteria are fulfilled
- Benefit risk analysis and risk management documentstion
- Results of critical verification and validation testing
- Pre-clinical data
- Clinical evalution and Post market clinical follow-up pland and reports
- Post market surveillance plans and Periodic safety update reports
- Additional information is required for
- Devices incorporating a medicinal substance
- Devices utilizing animal or human tissue
- Substance based devices
- Devices containing CMR or endocrine-disrupting substances
- Sterile devices
- Device with a measuring function
- Devices intended to be connected in order to operate as intended
At Qserve, we bring deep domain knowledge and real-time regulatory intelligence to help you compile your submission file and support you in the submission process. How we help:
- Global Regulatory Strategy: We work with you to define a streamlined global strategy that maps out regulatory pathways.
- Market-Specific Dossier Preparation. We tailor technical documentation to meet each regulatory body’s requirements. Whether it's a 510(k), De Novo, PMA, or EU MDR Technical File, our consultants prepare complete and strategically positioned submissions to withstand scrutiny.
- Gap Assessments. We review your current documentation and processes against applicable regulations and identify where updates or additional evidence (e.g., clinical, risk, labelling) are needed.
- Agency/Notified Body Interface. We manage questions, deficiency letters, and negotiations.
By partnering with Qserve, you gain regulatory clarity early, avoid costly missteps, and speed up your time to approval.
Satisfied Clients
Our Dossier Submission Support services cover multiple disciplines. Discover them all:
Submission file / documentation MDR
We structure, compile, and write complete submission files aligned with current regulatory MDR standards, ensuring consistency and traceability across all required components. Our team manages the end-to-end documentation process, from gap assessments to final dossier delivery.
US FDA submission support for PMA, pre-submission, and DeNovo 510(k)
We provide strategic and hands-on support for all FDA pathways, including pre-submission meetings, 510(k), De Novo, and PMA filings. Our experts ensure your submissions are scientifically robust, well-structured, and aligned with FDA expectations.
Submission file / documentation for country registration
We prepare localized dossiers based on global technical files, adapting documentation to meet the specific regulatory requirements of each target country. Our team manages translations, formatting, and region-specific annexes to streamline international registrations.
Preventing loss and inefficiency in dossier submission starts with having a well-organized regulatory strategy and cross-functional coordination. You must establish clear ownership of submission tasks, ensure all stakeholders understand regulatory timelines, and maintain consistent documentation standards across departments.
At Qserve, we help you establish a robust submission framework by bringing structure, expertise, and end-to-end support to the entire dossier process. From identifying gaps in your existing documentation to building high-quality, regulator-ready files, we streamline every step to avoid inefficiencies.
Couldn't find your question?
What are common causes of submission delays or rejections?
Delays often stem from incomplete documentation, misaligned internal timelines, outdated technical files, or unclear regulatory strategies. Late-stage scrambling and poor team communication can lead to errors or gaps that trigger regulator questions.
How does working with a consultancy reduce risk in dossier submissions?
A consultancy brings structure, experience, and a proactive approach to the submission process. We identify documentation gaps early, align teams, manage timelines, and ensure your submission meets the specific requirements of each target market.
Can you support both U.S. and international submissions?
Yes. We provide full support for FDA submissions (including 510(k), De Novo, PMA, and pre-subs) and dossier preparation for EU MDR, UK, Canada, and other global markets. We also help localize and adapt your files for efficient multi-country registration.
How early should we involve regulatory support in product development?
Ideally, regulatory input should begin at the concept or design phase. Early engagement helps define the correct regulatory pathway, avoids rework, and ensures that technical documentation and clinical data collection align with market expectations.