Thank you for your interest in our services. Please complete the form below and let us know how we can support your organization.
At Sterling Medical Registration we provide Regulatory and Quality Assurance Consulting Services for Medical Device Manufacturers, including support with FDA submissions, EU MDR compliance, ISO 13485 implementation, internal audits, risk management, and overall regulatory strategy. If you are seeking expert guidance, feel free to describe your needs in the form.
Looking for editable, Premium Quality Procedures - You are also welcome to explore our Store of Procedures, offering fully editable, premium‑quality templates designed to meet FDA QMSR 21 CFR 820, ISO 13485:2016, and EU MDR 2017/745 requirements. Our documentation - covering Quality Manual, Document Control, Risk Management, CAPA, Internal Audit, Training, Complaint Handling, Medical Device Reporting (Vigilance), Design Control, Labeling, Sterilization Validation, Supplier Control, and more - ensures smooth compliance, no duplication, and easy approval by certification bodies.
If you would like personalized assistance, you may use this form to ask a question, request a consultation, or book a Zoom appointment with one of our specialists. Please include any relevant details so we can respond effectively.