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]
How long providing this service? 16