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Protect records and meet the ALCOA+ requirements.
Assure compliance for connected devices and their technology evolution.
Avoid slowdowns and costs by preventively assessing every risk.
Design your site in compliance with the latest regulations.
Qualification services for all process, equipments and facilities’ matters.
From the regulatory strategy to the editing, amendment and submission of all documents.
Looking for more services?
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.
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.
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!
ISO 9001 Certified compliance services provider since 1998.
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