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BQC Consulting

Contact:  Nevine Erian, MSQA, MBA, CQE - Principal Regulatory & Compliance Consultant
Specialty: Submissions, Compliance and Remediation

BQC Consulting provides medical device firms with strategic Quality, Compliance and Regulatory solutions, integrating business needs, regulatory requirements and processes. 

Our services are founded on the following tenets:  due diligence, integrity, and a passion for excellence. 

We offer our clients value-added services, bringing a return on their investment.   We strive to ensure patient safety, product equity and regulatory risk aversion. 

Services Offered

U.S., Canada & EU Compliance ServicesQSR, CMDR, ISO 13485:2016 & MDD

  • Gap analysis, developing, improving and implementing quality systems
  • Preparing clients for an FDA/ISO/MDD Inspection/Audit
  • Acting as Quality Management Representative
  • Performing Internal & Supplier Audits
  • QSR & ISO Training programs
  • MDR & Vigilance Reporting
  • Performing regulatory due diligence for suppliers & acquisitions
  • Technical writing of policies and procedures

Addressing Regulatory Actions

  • Representing clients during an FDA Inspection/ISO Audit
  • Remediation of 483 and Warning Letter observations
  • Managing Product Recalls & Safety Alerts

Submissions, Technical Files & Registrations

  • FDA 510(K)s
  • U.S. Establishment Registration & Device Listings
  • Health Canada Medical Device License Applications & Amendments
  • Technical Files for CE Marking
  • State of California – DPH registration

Design & Development Support

  • Overall Design Project Management
  • Design Control support, including design verification and validation
  • ISO 14971 Compliance – Risk Management throughout product life cycle

 

Years in business:  13

 

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alt  www.bqcconsulting.com