Sterling Medical Registration
Sterling Medical Registration specializes in regulatory and quality consultation for medical device companies worldwide. They assist in establishing quality systems, product registration, and compliance with international standards and regulations, including ISO 13485:2016, MDSAP, and EU MDR. Their mission is to help medical device businesses develop a solid foundation, improve quality targets, and expand into global markets.
Industries
Nr. of Employees
small (1-50)
Sterling Medical Registration
Woodland Hills, California, United States, North America
Services
Implementation of a medical device quality management system to meet applicable standards and regulatory requirements (e.g., ISO 13485, FDA QSR).
Ongoing QMS support including document control, record retention and updates to maintain compliance.
Execution of internal audits and supplier/subcontractor external audits to verify QMS compliance and supplier performance.
Clinical evaluation services, study design and protocol development, and management of retrospective and prospective clinical studies.
Market requirement assessments, product classification, registration submissions, labeling and maintenance of regulatory licenses across jurisdictions.
Acting as or managing appointment of an EU authorised representative, providing mandate management and correspondence with competent authorities.
Implementation of a medical device quality management system to meet applicable standards and regulatory requirements (e.g., ISO 13485, FDA QSR).
Ongoing QMS support including document control, record retention and updates to maintain compliance.
Execution of internal audits and supplier/subcontractor external audits to verify QMS compliance and supplier performance.
Clinical evaluation services, study design and protocol development, and management of retrospective and prospective clinical studies.
Market requirement assessments, product classification, registration submissions, labeling and maintenance of regulatory licenses across jurisdictions.
Acting as or managing appointment of an EU authorised representative, providing mandate management and correspondence with competent authorities.
Expertise Areas
- Regulatory compliance and market registration (US, EU, Canada, Israel and other markets)
- Quality management system implementation and maintenance (ISO 13485, QSR)
- Clinical evaluation and clinical study design
- Biocompatibility and product testing coordination
Key Technologies
- ISO 13485 quality management systems
- Medical Device Single Audit Program (MDSAP)
- ISO 14971 risk management
- ISO 10993 biocompatibility testing