BQC Consulting LLC – Regulatory, Quality & Compliance Consulting

Contact: Nevine Erian, MSQA, MBA, CQE – Principal  Regulatory & Quality Consultant

 

Specialty: Medical Devices  – Submissions, Compliance, Remediations & Project Management

BQC Consulting provides biotech 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) submissions, Health Canada applications, EU Technical Files, facility registrations and Device Listings

  • Regulatory Remediations

483, Warning Letters, ISO/MDR audit findings & Product Recalls

  • U.S., Canada & EU Compliance

QSR, CMDR, ISO 13485, MDSAP & MDD to MDR QS implementation and UDI

  • Design & Development Support

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

 

Nevine Erian has 24 years of experience in the biotech industry.  Medical device experience includes disposables and capital equipment. Technologies include dental devices, audiometers, lipoplasty, nanoparticles, orthopedic implants & surgical instruments, intravenous catheters, EKG monitoring, sterilization equipment, hypothermia devices, drug eluting stents, and biocide solutions.

Phone:                    949 370–7155

Email:            [email protected]

Website:       www.bqcconsulting.com

How long providing this service? 16