IVD regulatory consulting services to achieve IVD compliance

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

Regulatory IVD services

IVD Regulatory consulting

Are you developing or selling in vitro medical devices or companion diagnostics? Qserve helps IVD manufacturers with IVD regulatory consulting services in all product life cycle phases to achieve IVD compliance and facilitate market access in multiple regions globally. Qserve's IVD experts all have industry experience and can support every step in the design and development process, including regulatory submissions, US FDA submissions, pre-submissions, the EU-IVDR including the transition from IVDD to IVDR, and on-market support.

Many manufacturers are changing their market entry strategy and will enter the US market first but want to repurpose data for Europe. Whilst the regulatory systems are very different, there is commonality, particularly if guidance such as Clinical Laboratory Standard Institute (CLSI) guidance is applied in design and development. Our team can help write submissions using this data to support global submissions.  

 

Regulatory, Quality, and Clinical Services

How can we help?

Qserve is an all-service IVD consultancy that can provide IVD regulatory consulting services throughout the product life cycle. Whether you are a start-up company, a small-medium enterprise (SME), or an established or multinational company, Qserve has services that can support your needs, whether you need expert knowledge or resources to augment your own quality and regulatory groups.

New device

  • Discuss strategy, first market entry, regulatory challenges and opportunities.
  • Focus on the intended purpose as this drives the design & development plan.
  • Explain the requirements, evaluate existing data, and how to fill the gaps.
  • Explain how to implement the QMS using a phased approach so essential procedures are in place at the right time while also spreading your budget.  

New markets and Commercialization

  • Support strategy discussions to enter new markets. This could be a design change, a change to the intended purpose in your existing market, or entering a new geographical region.
  • Qserve has staff based in the US, Europe, UK, and China. Through our Global Registration Team, we can support regulatory submissions from the US FDA, EU-IVDR, China, and the rest of the world. 
  • Market access is supported by EU Authorized Representation, US Agent, UK Responsible Person, China Agent services, and worldwide market access through our partnership network.  
  • A comprehensive suite of training covering all elements of IVD regulations and QMS implementation. 

Design and development process

Product Life Cycle Support

  • Qserve has real-world experience and provides a practical approach to all steps of the design and development process for IVDs.
  • Our IVD team can help start-up projects navigate all elements of the process.
  • We can also help existing companies navigate the impact of design changes on regulatory submissions.
  • We can discuss science with your IVD teams and converse with your quality and regulatory professionals to find the most effective and compliant solutions. 

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Download the IVD design and development process to learn more about the steps in the product life cycle.

Download IVD leaflet

Product Life cycle phases

IVD regulatory consulting services

Initiate & Plan

  • Define regulatory market access strategy
  • Determine appropriate market access pathways
  • US:
    • FDA: Determine classification and appropriate approval route e.g. PMA, 510(k) or Denovo 510(k)
    • Determine whether a device is eligible to be considered a breakthrough device
    • Prepare for a pre-submission meeting with FDA
  • EU:
    •  Determine classification and discuss borderline issues
    • Plan or update EU-IVDR transition plans
    • Notified Body selection and communication
    • Determine an IVDR-compliant intended purpose
  • Perform a gap assessment of available analytical and clinical data or technical file
  • Perform a gap assessment of QMS and provide procedures to close the gaps
  • Perform due diligence assessments of key subcontractors or companies as part of merger and acquisition activities

Develop

  • Develop a compliant verification and validation plans/ Performance evaluation plan (PEP)
  • Implementation of design control to meet ISO 13485 / 21CFR820
  • Risk Management to ISO 14971

Verify

  • Support QMS Implementation, including process validation and design freeze prior to verification and validation
  • Support to write design control documentation  to confirm design output meets design inputs
  • US: Prepare or support the preparation of analytical study summaries and reports for FDA Submissions
  • EU: Prepare or support the preparation of analytical performance reports 

Validate & Transfer

  • Support to implement or audit QMS to ISO 13485/ 21CFR820 requirements, including transfer to manufacturing, implementation of complaints and CAPA, post-market requirements, and adverse event/ vigilance reporting.
  • US: 
    • Support to apply for ethics committee and IDE to perform clinical studies
    • Prepare or support the preparation of method comparison or clinical studies for FDA Submissions
    • Compile or review 510(k) or PMA submission
  • EU:  
    • Pre-Notified Body audit to IVDR to Annex IX
    • Audit to ISO 15189 for testing laboratories used in clinical trial assays or as part of distance sales
    • Support to apply for ethics committee and clinical performance studies
    • Monitoring clinical performance studies.
    • Training on how to conduct and monitor studies to ISO 20916.
    • Prepare or support the preparation of clinical performance reports and performance evaluation reports (PER)
    • Compile IVDR Technical file
Commercialize
  • Market access support
  • US:
    • US Agent service for foreign manufacturers
    • Support to apply for a US Establishment license
  • EU:
    • EU Rep service for foreign manufacturers
    • UK Responsible Person service
  • Support to implement Post-Market Surveillance, Vigilance, and PMPF plans and reports
  • Support to when to report design changes/significant changes
  • Auditor services, including pre-submission, supplier, internal, and due diligence audits)

Interested in Qserve's IVD regulatory consulting 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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