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

Data Integrity

Data Integrity

Protect records and meet the ALCOA+ requirements.

Digital Governance

Digital Governance

Assure compliance for connected devices and their technology evolution.

Compliance

Compliance

Avoid slowdowns and costs by preventively assessing every risk.

Technical Qualification

Commissioning & Qualification

Qualification services for all process, equipments and facilities’ matters.

Quality Engineering

Quality Engineering

Design your site in compliance with the latest regulations.

Regulatory Affairs

Regulatory Affairs

From the regulatory strategy to the editing, amendment and submission of all documents.

Trainings

Trainings

Prepare to successfully pass audits and inspections with our cost-effective training courses.

Audits

Audits

From internal audits, to suppliers’ qualification or routine monitoring for due diligence purposes.

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!

Stay tuned for a comprehensive breakdown that will empower medical device manufacturers to navigate the FDA inspection process with confidence!