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Protect records and meet the ALCOA+ requirements.
All-in-one solutions to coordinate your digital development.
Avoid slowdowns and costs by preventively assessing every risk.
Level up your laboratory to its highest potential.
Design your site in compliance with the latest regulations.
A modern and integrated approach to qualification.
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.
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,
a comprehensive breakdown that will empower you to navigate the FDA inspection process with confidence!
ISO 9001 Certified compliance services provider since 1998.
PQE US Inc. Headquarters:
Twinbrook Parkway 12300, 20852 Rockville, MD
Local Units:
Raleigh (NC), Cambridge (MA), Libertyville (IL), Buffalo (NY), San Diego (CA)
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