Consulting services in the framework of MDR/ MDD, ISO 13485, MDSAP, ISO 9001, FDA-510(K) and 21 QSR 820, HC (SOR/98-282) , Brazil (ANVESA and INMETRO)
Audit and QMS analysis utilizing qualified medical device auditors for ISO 13485, ISO 9001 MDR/ MDD requirements, MDSAP , FDA 21QSR820, INMETRO
Quality system development and internal auditing
Preparation and response to nonconformities and deficiencies issued by Notified Bodies and regulatory authorities
Supplier audits
Design dossier submission review in compliance with MDR/MDD requirements
Systematic approach audits, evaluation and project based specific reviews and analysis depending of your company’s needs
Regional and international market specific requirements assessment
SAZA Consulting is comprised of industry-specific experts who offer professional advice, guidance, and actionable solutions to medical device companies experiencing issues they can't deal with in-house. We help organizations manage change and solve problems, so they operate more efficiently and therefore profitably. SAZA Consulting assist organizations in achieving conformance with government regulations and help develop processes and programs to ensure organization-wide compliance with applicable laws and standards.
The president and CEO of SAZA Consulting, Sam Shakir has an academic background in Pharmacy and working experience in Medical Device Industry and Notified Body as a Manager and senior consultant for more than 10 years of experience in quality and regulatory affairs. Deep knowledge in delivering the highest standards in a timely manner and with outstanding customer services.
We strive to provide truthful and accurate consultations following ethical and transparent approaches.
Phone: 301-339-3448
Address: 2563 Windmill View Rd, El Cajon, CA 92020
SAZA Consulting © 2023