Medical Device Solutions
We are providing regulatory and quality consulting services to the medical device industry. Navigation and streamlining the global regulatory arena!
5 Tips for Medical Device Registration Across Global Markets
Do you want to start your business, so need to know the process of medical device registration...
Do I need an importation license to sell my product in US?
Need help understanding if you need a license? We can help you navigate through all the regulatory...
I have a product that needs registration with FDA
Want to learn more about how your product is regulated in USA? Global RQC can help you navigate...
We are a proud member of
Regulatory Affairs Professional Society (RAPS – RAC)
American Society For Quality (ASQ – CQA)
Medical Devices Consultancy Services
Regulatory Affairs
Regulatory Submissions
Regulatory Submissions (510(k), MDL, Technical Documentation)
New Product
New Product Development Pathways
Registrations
Registrations & Device Listings
Regulatory Compliance
Global Regulatory
Global Regulatory Intelligence and Consulting
Independent Reviews
Independent Reviews for 510(k) Submissions
Combination Product
Combination Product – Regulatory Strategy
Regulatory Compliance
Remediation Strategies
483 Findings NB Findings Mock Audit Preparation
Regulation
Regulation (EU) 2017/745
CAPA
Corrective and Preventive Action (CAPA)
Audits
FDA QSR 820 & ISO 13485 Audits
Quality System
QMS Development
QMS Development
FDA QSR 21 CFR 820
FDA QSR 21 CFR 820
ISO 13485:2016
ISO 13485:2016
QMS Gap Analysis
QMS Gap Analysis
We also Offer
Regulatory Compliance
MRSubmissions
Market Research
Development Cost
Business/Product Development Cost
Testimony
Testimony
Expert Witness Testimony
Expert Witness Testimony
Corporate Due
Regulatory/Quality Corporate Due Diligence