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BQC Consulting LLC

Contact:  Nevine Erian, MSQA, MBA, CQE - Consultant
Specialty: Submissions, Compliance, Remediation & Project Management

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

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

Services and areas of expertise include:

  • Submissions, Technical Files & Registrations

510(k) & IDE submissions, Health Canada applications, EU Technical Files, facility registrations and Device Listings

  • Regulatory Remediations

483, Warning Letters, ISO/MDR audits & Product Recalls

  • U.S., Canada & EU Compliance

QSR, CMDR, ISO 13485, MDSAP & MDD/MDR QS iimplementation/rehaul and UDI implementation

  • Design & Development Support

Design Project Management, Design Control support, including guidance in design verification and validation, and ISO 14971 Compliance 

Nevine Erian has 23 years of experience in the biotech industry.  Medical device experience includes disposables and capital equipment. Technologies include dental devices, audiometers, nanoparticles, orthopedic implants & surgical instruments, intravenous catheters, EKG monitoring, sterilization equipment, hypothermia devices, drug eluting stents, and biocide solutions. 

Years in business:  15

(949) 370-7155
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