RegulatoryQualityCompliance

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
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

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Regulatory Submissions

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

New Product

New Product Development Pathways
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Registrations

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

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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

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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)