IVD Consulting with Qserve IVD consultancy experts

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

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Expertise
IVD Consulting with Qserve IVD consultancy experts

IVD CONSULTANCY

IVD consulting experts

Are you looking for an experienced regulatory IVD consulting company with in-house 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.

Qserve IVD consulting

Qserve's IVD consulting team has supported many IVD manufacturers around the world, from start-ups to small-medium companies as well as multinationals. We have experience with a broad spectrum of IVD devices and technologies, with a special interest in Companion Diagnostics (CDx).
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 for inclusion in global regulatory submissions.
Our experts have worked in the IVD industry for startups, global players, and notified bodies, which provides the team with a rounded perspective of European regulations. Whether you are transitioning from the IVDD to IVDR, our team can help you determine the most effective way for your organization, the challenges you face, and how to create submissions in a Notified Body-friendly and compliant format.
The IVD team also has many years of practical experience with the US FDA regulations, guidance, and how to apply them to your product development efforts; this is 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, including the challenges of meeting multiple countries with one set of data.

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Key expertise areas:

US FDA & EU Regulatory Affairs and Quality Assurance
US FDA submission support for PMA, pre-submission, and 510(k), including denovo 510(k)
EU-IVDR regulatory support and CE marking
Companion Diagnostics (CDx)
Distance Sales
We take a practical approach to all the steps of the IVD design and development process, including analytical and clinical performance.
Clinical Performance Studies for IVD and CDx, including application of ISO 20916
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
Auditor services pre-submission audits, supplier audits, internal audits, due diligence audits

IVD services

Your IVD consulting partner

Are you thinking about using an external regulatory affairs consultant?

Qserve is a full-service medical device and IVD consultancy and CRO that shares 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?

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Expand your knowledge

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

Qserve has developed customized training sessions to not only teach the requirements but also coach clients through hands-on workshops. In these workshops, clients gain a greater understanding of the requirements, 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 to support EU, US FDA, or Rest of the World (ROW) regulators."