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

Independent Reviews

Independent Reviews for 510(k) Submissions

Medical Device Consultant: Ensuring Quality

We are a medical device consultant who will help provide your patients with the best care possible by ensuring each medical device you use meets applicable regulatory requirements. We use a client-centric business model that focuses on the specific needs of each client and their potential medical device. As a medical device consultant, we identify the key market indicators, time to market, and commercialization of the machine before you bring it to your practice. We ensure all statutory and quality regulations and compliance issues are addressed early in the development stage through stage-gate defined regulatory strategy endpoints. This allows the business to develop parallel strategies that both are country and client-specific.

Our Process

We prepare global regulatory strategies, regulatory intelligence, and submissions. We do this in a complex matrix approach noting parallel and differences in specific markets.

 

  • Radiology (MRI, CT, Ultrasound, PET)
  • Nuclear Medicine (X-Ray, PACS)
  • Lasers & Fiberoptics
  • In-Vitro Diagnostics
  • Implants
  • Dental Devices

Request Information from our Specialists

Services Include: Regulatory Affairs

  • Regulatory Submissions (510(k), MDL, Technical Documentation)
  • Global Regulatory Intelligence/Consulting
  • New Product Development Pathways
  • Independent Reviews for 510(k) Submissions
  • Registrations & Device Listings
  • GMP Requirements
  • Combination Product – Regulatory Strategy

Services Include: Regulatory Affairs

  • Remediation Strategies
  • Corrective and Preventive Action (CAPA)
  • Medical Device Reporting (MDR)
  • Device History Files (DHF)
  • Remediation Strategies
    • 483 Findings
    • NB Findings
    • Mock Audit Preparation
  • FDA QSR 820 & ISO 13485 Audits
  • Quality System Gap Analysis

Others Services

  • Market Research
  • Business/Product Development Cost
  • Expert Witness Testimony
  • Regulatory/Quality Corporate Due Diligence