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IVD Consultancy

Qserve IVD regulatory consultants support you in all phases to achieve regulatory compliance.

IVD CONSULTANCY

Regulatory IVD consultants

Are you looking for an experienced regulatory consultancy with in vitro diagnostic specialists? Qserve created a team that can support manufacturers worldwide across the product life cycle to support the final device to be safe and effective. Our IVD regulatory consultants find the most efficient path to gain regulatory compliance. We understand the industry, identify your needs and gaps, and support you with successful submissions in the United States, Europe, and other parts of the world.


Why choose Qserve?

  • Qserve supported many IVD manufacturers around the world, from start-ups to small-medium companies and multinationals, with any type of IVD device, with a special interest in Companion Diagnostics
  • Our team understands both the science and how to develop IVDs, including how to write protocols and reports to support the generation of analytical and clinical performance data to create safe devices for the intended population and user for inclusion in global regulatory submission.  
  • Our experts worked in the industry for startups, global players, and Notified Bodies. This provides the team with a rounded perspective of European regulations from the IVDD to IVDR and how they are most effectively applied to your organization, the challenges you face, and how to create submissions in a Notified Body-friendly format.
  • The IVD also has many years of practical experience with the US FDA regulations, what guidances are out there, and how to apply them to your product development efforts based on first-hand experience with (premarket) submissions, 510k, and PMAs.
  • Manufacturers want to sell IVDs globally, Qserve has experts who have experience in preparing submissions for this global world as a coherent project and the challenges of meeting multiple countries with one set of data.

Contact us

Key expertise areas:

  • US FDA & EU Regulatory and Quality Affairs
  • US FDA submission support for PMA, pre-submission, and DeNovo 510(k)
  • EU-IVDR regulatory support and CE marking
  • Companion Diagnostics (CDx) and Distance Sales ISO 20916
  • IVD, CDx Development, Analytical and Clinical Performance Studies for IVD and CDx
  • Design Control
  • Literature Search to support scientific validity and state of the art
  • Risk Management to ISO 14971
  • Preparation of Technical Documentation
  • Quality Management Systems, ISO 13485, ISO 15189, MDSAP
  • Post-market Surveillance, Vigilance and Post Market Performance Follow Up (PMPF)
  • Software, algorithms, machine learning, AI, IEC 62304, usability
  • Auditor services pre-submission audits, supplier audits, internal audits, due diligence audits

We provide a practical approach to all the steps of the design and development process for IVDs.

 

IVD services

Your regulatory partner

Are you thinking about using an external regulatory affairs consultant? 

Qserve is a full-service Medical Device and IVD consultancy and CRO sharing 25 years of knowledge. All our projects are based on a team approach. Our experts have a passion for complex regulatory issues and go for the extra mile with a practical approach to support our clients. Do you want a first introduction?

Contact us

Expand your knowledge

We can support employees with customized training sessions for IVD and IVDR Services.

Qserve has developed customized training sessions to not only teach the requirements but educate clients through hands-on workshops where they gain a greater understanding of what the requirements are, industry best practices, and how to apply these to their own organization. Contact us to discuss the options for your business.

Training

“At Qserve, we created a dedicated IVD team that can support manufacturers across the product life cycle. We enable manufacturers to create safe devices for the intended population and user with good data that can then be packed to support EU or US FDA or Rest of the World (ROW) regulators." 

https://www.qservegroup.com/write/Afbeeldingen1/Collegas/Sue Spencer.png?preset=content

Sue Spencer | Head of IVD & Principal Consultant 

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