Navigation and Streamlining the Global Regulatory Arena!

(908) 809-0081

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

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

Medi Capture, Inc.

“James was contracted to set up a QMS, create two technical files, and write GSPR/Clinical Evaluation Plan..”

Medical Devices Consultancy Services

Regulatory Affairs


Regulatory Submissions

Regulatory Submissions (510(k), MDL, Technical Documentation)

New Product

New Product Development Pathways


Registrations & Device Listings

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 (EU) 2017/745


Corrective and Preventive Action (CAPA)


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


Market Research

Development Cost

Business/Product Development Cost


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)