We assist companies in bringing manufacturing facilities into compliance with FDA’s QMSR requirements (21 CFR Part 820), ISO 13485 standards, and MDR/IVDR requirements.
Comprehensive quality assurance documentation tailored to your operations
Standard operating procedures with hands-on training for your team
Complete design control implementation and compliance verification
Quality system assessment with corrective action recommendations
Comprehensive validation protocols for software-driven devices
Process validation protocol development and reporting
Evaluation and qualification of suppliers and contract manufacturers
Internal audit by an experienced and certified auditor
A. Stein Regulatory Affairs Consulting have participated in hundreds of QMSR and ISO 13485 inspections conducted by FDA inspectors and European Notified Body auditors. The vast majority of these audits reported no 483s or major deficiencies.
We provide expert support to medical device companies seeking to bring their manufacturing facilities into compliance with the FDA’s QMSR requirements as outlined in 21 CFR Part 820, as well as ISO 13485 standards and Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) requirements.
Our experienced team develops and implements comprehensive quality management systems, including the standard operating procedures and documentation necessary to meet both organizational needs and applicable regulatory requirements under the FDA QMSR, ISO 13485, and MDR/IVDR (2017/745 and 2017/746).
Let’s discuss how we can accelerate your path to global market access with clarity, efficiency, and consistent compliance.
Contact A. Stein Regulatory Affairs Consulting Ltd.
Address: 18 Hata’as St. Kfar Saba, ISRAEL , 4442518.
Phone: +972-9-767-0002
Email: office@asteinrac.com