Quality Management System Implementation Services
Quality Management System (QMS) Implementation Services
ISO 13485:2016 QMS Implementation
We support medical device companies in establishing, implementing, and maintaining a fully compliant Quality Management System aligned with ISO 13485:2016. Our approach ensures that your organization builds a robust, efficient, and audit‑ready QMS tailored to your operations, product risk, and regulatory markets.
Our ISO 13485:2016 implementation services include:
Gap Assessment & QMS Planning Conducting a detailed evaluation of your current processes and defining a clear roadmap to full ISO 13485 compliance.
QMS Architecture & Documentation Development Creating and organizing all required procedures, work instructions, templates, and records, ensuring alignment with regulatory expectations and your operational needs.
Risk Management Integration (ISO 14971) Embedding risk‑based thinking across product development, manufacturing, post‑market activities, and quality processes.
Process Implementation & Optimization Establishing compliant processes for design controls, supplier management, production, CAPA, complaint handling, PMS, internal audits, and more.
Training & Competency Development Providing targeted training for leadership and staff to ensure proper understanding and execution of QMS responsibilities.
Internal Audit & Management Review Support Preparing your organization for certification audits through internal audits, corrective actions, and management review facilitation.
Certification Readiness Guiding you through the certification process and supporting interactions with Notified Bodies.
FDA QMSR Implementation
In addition to ISO 13485:2016, we implement Quality Management System processes aligned with the FDA Quality Management System Regulation (QMSR), ensuring compliance with U.S. regulatory expectations. Our services include harmonizing your ISO 13485 framework with QMSR requirements, addressing FDA‑specific elements such as complaint handling, MDR reporting, and device listing/registration.
Overview of MDSAP
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple jurisdictions, including the United States (FDA), Canada (Health Canada), European Union (for auditing purposes), Japan (PMDA/MHLW), Brazil (ANVISA), and Australia (TGA).
MDSAP reduces duplication, saves time, and provides a harmonized approach to compliance across major global markets. Sterling Medical Registration guides you through MDSAP readiness, audit preparation, and ongoing system maintenance, ensuring your QMS meets the expectations of all participating authorities.
This overview positions your QMS services as globally comprehensive and highlights the added value of MDSAP for international manufacturers.
Comparison of Global Medical Device QMS Frameworks
Framework | Scope & Focus | Key Requirements | Market Coverage |
EU MDR 2017/745 | European Union medical device regulation | Technical documentation, clinical evaluation, PMS, vigilance, QMS aligned with ISO 13485 | Mandatory for CE marking in the EU |
ISO 13485:2016 | International QMS standard for medical devices | Quality Management System(QMS), management responsibility, resource management, product realization, measurement, analysis, and improvement. Risk management - risk based approach, process interaction, regulatory compliance. | Recognized globally as the baseline QMS standard |
FDA QMSR (21 CFR Part 820) | U.S. FDA Quality Management System Regulation | Similar to ISO 13485, but with specific requirements tailored to the U.S. market such as Unique Device Identification (UDI), complaint handling, and regulatory reporting. | Required for U.S. market clearance and inspections |
Canada (SOR/98-282) | Canadian Medical Device Regulations | QMS certification to ISO 13485, licensing, post‑market obligations | Required for medical device licensing in Canada |
MDSAP (Medical Device Single Audit Program) | Harmonized audit program across multiple regulators | One audit covering ISO 13485 plus country‑specific requirements | Accepted by FDA (U.S.), Health Canada, Brazil (ANVISA), Japan (PMDA/MHLW), Australia (TGA) |
EU MDR 2017/745 Adjustments
We also support organizations in aligning their Quality Management System with the requirements of the European Medical Device Regulation (EU MDR 2017/745). This includes integrating MDR‑specific expectations such as enhanced technical documentation, PMS and PMCF processes, clinical evaluation requirements, UDI implementation, and strengthened vigilance obligations. These adjustments ensure your QMS remains fully compliant for placing devices on the European market.
Tailored QMS Services for Your Regulatory Pathway
Every company operates within a unique regulatory landscape. Whether your focus is ISO 13485:2016 certification, FDA QMSR compliance, MDSAP readiness, or EU MDR alignment, we provide customized QMS solutions designed to meet your operational needs and the specific requirements of your target markets. Our goal is to deliver a structured, efficient, and compliant Quality Management System that supports your products, processes, and long‑term business objectives.