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(908) 809-0081

Available as needed after regular office hours | Hours of Operation: Monday – Friday: 8:00 AM – 6:00 PM

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Global RQC Med Device Solutions LLC
Hours of Operation :

Monday – Friday, 8:00 AM – 6:00 PM

Available as needed after regular office hours.

Address: Somerset, NJ 08873
Phone: (908) 809-0081

Global RQC

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Product / Services (United State)

Pre-submissions

510k Regulatory Submissions

De Novo Strategies

21 CFR 820 Quality Management System Development

FDA 483 Remediation Strategies

Mock Audits

Pre-market Approval Process

Product / Services (European Union)

EU MDR 2017/745

ISO 13485:2016 QMS Development

CE Marking Gap Analysis : Class 1 Class 2 Class 3 Class 4

Product / Services (Canada)

MDSAP Audit Preparation MDL Submissions : Class 1 Class 2A Class 3B Class 3

Product / Services (Others)

Global Regulatory Strategy Development

Corporate Regulatory/Quality Due Diligence

Expert Witness Testimony

New Product Business Development

Marketing Strategies

Speaking Engagements

Corporate Training

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Regulatory Quality Compliance

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About Us

Over the past 20 years, James has been exclusively involved in the medical device field, focusing on Regulatory Affairs and Quality Assurance. Within this arena, he has focused on getting medical devices registered globally.

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Global RQC Med Device Solutions LLC
Somerset, NJ 08873
Phone : (908) 809-0081
Email : sales@globalrqc.com

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