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IVD regulatory services

Qserve is a full-service IVD consulting partner for US FDA IVD regulation and EU IVDR regulation.

IVD Regulation services

Regulatory IVD services

Are you developing or selling in vitro medical devices or companion diagnostics? Qserve helps IVD manufacturers in all product life cycle phases to get IVD compliance and to keep the product on the market according to IVD regulations in different countries. Every step in the design and development process for IVDs can be completed and helps you to get regulatory approval. 

Our IVD consulting experts fully understand the EU IVDR regulation, the transition from IVDD to IVDR, the FDA IVD requirements in the US, and pre-submission review, which can help you enter the US medical device market sooner and directly through the proper route to the FDA. 



Regulatory, Quality, and Clinical Services

How can we help?

Qserve is an all-service IVD consultancy. Whether you are a start-up company, a small-medium company, established or multinational, Qserve can step in with all your needs and offers different service packages.

New device
Qserve discusses the intended purpose and helps you out with the design & development plan and regulatory market access strategy. 

Change of design or regulations 
Discuss the necessary requirements, evaluate existing data, and step into the gaps you need to fulfill to adjust the QMS. Qserve helps you with all the steps in the transition from IVDD to IVDR. 

New markets 
We support regulatory submission support for the US FDA, EU-IVDR, and the rest of the world countries. We help you with the most efficient regulatory pathway, how the regulatory requirements comply with your existing data and documentation, and the gaps you need to fulfill.

Commercialize
We ensure your developed device is ready for commercial distribution and support device labeling, training materials, and regulatory submissions. Qserve offers strategy tools and templates for Post Market Surveillance and PMPF and supports internal audits. 

 

Design and development process

Follow the journey

Qserve provides a practical approach to all steps of the design and development process for IVDs. Once all the phases are complete, your developed device is ready for commercial distribution.

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Engage with experts from the field
IVD and medical device requirements structurally look similar. However, if you need support for analytical and clinical performance, you really could use expert knowledge for these specific scientific studies.

Our experts worked in the industry and have industry design and development skills combined with regulatory knowledge. Download the IVD design and development process to learn more about the journey and the IVD experts.  

Download IVD leaflet

Product Life cycle phases

How we can support

  1. Initiate & Plan 
    What is the intended purpose/use of your device?
    Gap Assessment Technical
    Gap Assessment QMS
    Regulatory Market Access Strategy
    Due Dilligence
    US: FDA submission support for PMA, pre-submission, IDE, Denovo 510(k), CDx determinations
    EU: Planning or adjusting EU-IVDR, Notified Body selection and communication

  2. Develop
    Project Plan
    Design Control
    Quality Management System Support
    Implement Selected QMS Processes ISO 13485 / 21CFR820
    IVDR Annex IX, ISO 13485, ISO 15189. ISO 20916
    Technical documentation support
    Clinical and Performance Evaluation Studies for IVD and CDx
    Risk Management to ISO 14971


  3. Verify
    In this stage, the design verification reports need to confirm design output meets design input requirements.
    Process validation plan
    Design validation plan
    Complete QMS Implementation
    US: Prepare FDA Submissions
    EU: Implement IVDR Specific Requirements into QMS 

  4. Validate & Transfer
    To ensure the developed device conforms to customer requirements and intended use. Confirmation in the process validation reports the device design is correctly translated into production specifications.
    US: Apply for a US Establishment license
    EU: Compile IVDR Technical file 

  5. Commercialize
    The last steps to ensure your developed device is ready for commercial distribution.
    US Agent service for foreign manufacturers
    EU Rep service for foreign manufacturers
    Post Market Surveillance, Vigilance and PMPF plans and reports
    Design Change Management
    Auditor services (pre-submmission, supplier, internal, due diligence)
 

Interested in Qserve's IVD regulatory services?

Can you use assistance in one or more phases of the product life cycle for your in vitro medical device? We want to help you with the challenges you might have designing devices for multiple markets, changing or setting up your market access strategy, or preparing appropriate regulatory submissions.

Contact us

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