A. Stein Regulatory Affairs Consulting provides full-spectrum regulatory management across all major pathways and global markets, ensuring your device reaches patients faster while maintaining rigorous compliance standards.
Comprehensive review and strategic planning for FDA marketing clearance/approval
Comprehensive review and strategic planning for CE Certification according to MDR/IVDR
Since 1996, A. Stein Regulatory Affairs Consulting has helped clients obtain hundreds of 510(k) clearances for a wide range of devices, including Medtronic, Mazor Surgical Technologies, Brainsway, Rimed, InMode, and Lumenis. We routinely draft and submit Regulatory Strategy documents, Pre-Sub/Q-Sub packages, IDEs, RFDs, and 513(g)s to the FDA, and engage in regular FDA meetings to advance submissions. Our track record also includes successful 510(k)s, De Novo Classification Requests and PMA approvals and extensive preparation for FDA inspections of quality systems as well as Notified Body audits.
As part of FDA regulatory clearance and approval, A. Stein Regulatory Affairs Consulting has supported numerous BIMO (clinical) inspections, including site visits in the US, Europe, and Israel, as well as sponsor inspections. The firm has also participated in hundreds of QMSR and ISO 13485 inspections conducted by FDA inspectors and European Notified Body auditors, respectively. The vast majority of these audits have reported no 483s or major deficiencies.
Our track record includes engaging FDA early in Pre-Sub/Q-Subs, IDEs, with subsequent successful regulatory submissions including 510(k)s, De Novo Requests and PMAs.
Comprehensive review and strategic planning for FDA & CE marketing approval
Obtain FDA guidance on development and planned submissions, helping reduce risk and clarify expectations.
Efficient IDE submissions to expedite clinical study initiation
Premarket notifications successfully demonstrating substantial equivalence to predicate devices
Complete support for Class III devices and novel device classifications
Registration of companies and Listing of medical device, as well as US Agent services
A. Stein Regulatory Affairs Consulting assists companies in obtaining CE Certification in accordance with the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Our regulatory team has the expertise to guide our clients through the maze of regulatory requirements, including finding an appropriate Notified Body to grant certification, prepare the required Technical Documentation and lead our clients through the long and arduous process.
A. Stein Regulatory Affairs Consulting can participate in all audits performed by Notified Bodies to inspect Technical Documentation and Quality Management Systems and assist with any required corrective actions.
Prepared for Notified Body / Authorized Representative Review per EU Regulation 2017/745 and 2017/746
Authorized Representative Selection Assistance for EU MDR/IVDR Entry
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
