Medical Device & IVD

Medical Device & IVD

Register and certificate your Medical Devices and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device vigilance.

Support packages

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Data Integrity

Protect records and meet the ALCOA+ requirements.

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Digital Governance

All-in-one solutions to coordinate your digital development.

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GxP Compliance

Avoid slowdowns and costs by preventively assessing every risk.

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Laboratory Excellence

Level up your laboratory to its highest potential.


Engineering & Construction

Design your site in compliance with the latest regulations.


Commissioning & Qualification

A modern and integrated approach to qualification.

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Regulatory Affairs

Edit, amend and submit the dossier and registrate worldwide.



Perform and customize trainings for your personnel.



Perform all type of audit, either remotely or onsite.

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Clinical Research

Streamline drug development with tailor-made CRO services.

Looking for more services?

How can we help?

Getting in touch directly with us is the best way to let us understand your needs.

A roadmap to EU MDR/IVDR

PQE Group offers a specific regulatory support to any MD or IVD businesses looking to launch on the European market, needing guidance with CE Markings or wanting to ensure business continuity and renewal.

Book your first assessment with our team of experts and set up a time-tested strategic action plan to effectively and competitively manage regulatory compliance.

Cybersecurity for connected MD and IVD

New cases of malware and software infections are spreading everyday, exploiting the newest technologies and putting patient’s safety at risk.

Follow our guide and defend both your medical device or in vitro diagnostics products and your users.

Beyond Borders: Navigating FDA Inspections
for Medical Devices Globally

Dive into the world of FDA inspections for medical device manufacturers with our A-Z Guide series,
a comprehensive breakdown that will empower you to navigate the FDA inspection process with confidence!