Medical Device Solutions
We are providing regulatory and quality consulting services to the medical device industry.
Navigation and streamlining the global regulatory arena!
Dan Krause, MSc.
“Our expert software consultant on the submission thought that you and your team..”
Marc Barrette
“We look forward to working with him on many other projects in the future. He is a very knowledgeable consultant..”
SGS North America Inc.
“GRQC has documented procedures that have been created for all applicable processes per ISO
13485:2016..”
Medi Capture, Inc.
“James was contracted to set up a QMS, create two technical files, and write GSPR/Clinical Evaluation Plan..”
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Medical Devices Consultancy Services
Regulatory Affairs
Regulatory Submissions
New Product
Registrations
Global Regulatory
Global Regulatory Intelligence and Consulting
Independent Reviews
Independent Reviews for 510(k) Submissions
Combination Product
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 Systems
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
MR
Market Research
Development Cost
Business/Product Development Cost
Testimony
Expert Witness Testimony
Corporate Due
Regulatory/Quality Corporate Due Diligence
We Are A Proud Member Of
Regulatory Affairs Professional Society (RAPS - RAC)
American Society For Quality (ASQ - CQA)
Global RQC Med Device Solutions, LLC. has assisted Boston Scientific recently received clearance of their device K151613, ILab Polaris Multi-Modality Guidance System, an Intravascular Ultrasound Imaging System, featuring its imaging modality, Fractional Flow Reserve (FFR). The FDA in its assessment of the responses to their additional questions stated: “ ‘Our expert software consultant on the submission thought that you and your team did such a great job at addressing the questions contained in our Additional Information request, that he has forwarded your responses to the “Cardiac Diagnostic Devices Branch Hall of Fame” to serve as a prime example of a comprehensive response to concerns such as the Cybersecurity and Interoperability of devices, among others. ’ “
The work Global RQC Med Device Solutions, LLC. has done with us has been invaluable in helping
us to achieve our goal.
James has been an invaluable resource for all our regulatory requirements with the FDA. With his guidance and assistance, we were able to navigate through a complex 510(k) submission and bring our medical device to the U.S. market. James is currently creating a Quality Management System to ensure that we are compliant with FDA audit requirements. We look forward to working with him on many other projects in the future. He is a very knowledgeable consultant and has a network of associates in the industry with whom he can get answers to all your regulatory questions. His consulting rates are more than reasonable and he is an all-around nice person to work with. I highly recommend him and would be happy to speak with anyone looking for recommendations .
The work Global RQC Med Device Solutions, LLC. has done with us has been invaluable in helping
us to achieve our goal.
“Regarding Global RQC Med Device Solutions, LLC (GRQC), Quality System Development: GRQC has documented procedures that have been created for all applicable processes per ISO 3485:2016. These procedures generally include the documented requirements. The consideration for implementing risk levels within the lifecycle of the product is evident. It is also evident that risk was considered per the level of risk of each quality management process.”
knowledgeable consultant and has a network of associates in the industry with whom he can get answers to all your regulatory questions. His consulting rates are more than reasonable and he is an all-around nice person to work with. I highly recommend him and would be happy to speak with anyone looking for recommendations.
The work Global RQC Med Device Solutions, LLC. has done with us has been invaluable in helping
us to achieve our goal.