We specialize in the development, implementation, and optimization of Quality Management Systems (QMS) in full compliance with EN ISO 13485. Our services are tailored to meet the regulatory and operational needs of medical device and in vitro diagnostic (IVD) manufacturers. Whether you’re bringing a product to market or maintaining compliance under the EU MDR, IVDR, or FDA QSR, we guide you through every step of the quality journey.
Our ISO 13485 QMS Services
We provide comprehensive support, including:
- Design & Implementation of ISO 13485-Compliant QMS
Full setup of a custom quality system, including documentation, process controls, and training. - Integration with Regulatory Standards
Harmonized implementation of ISO 14971 (risk management), EU MDR 2017/745, IVDR 2017/746, and FDA 21 CFR Part 820 to ensure global compliance. - Technical Documentation & CE Marking Support
Assistance in compiling compliant technical files and preparing for Notified Body assessments. - Internal Audit & CAPA Support
Planning and execution of internal audits, deviation management, and continuous improvement. - Staff Training & QMS Coaching
Customized training sessions on ISO 13485, audit readiness, risk management, and post-market surveillance.
Global Experience in MedTech Compliance
With over 15 years of international experience, we have helped manufacturers across Europe, North America, Asia, Latin America, the Middle East, Africa, and Australia achieve and maintain ISO 13485 certification. Our customers range from startups to global organizations and cover a broad spectrum of device risk classes. From implantable and active devices to SaMD and diagnostics.
eQMS Systems We Work With
We are familiar with and can support the implementation of industry-leading electronic QMS platforms, including:
We help you choose the right system for your business and tailor it to fit ISO 13485 and MDR requirements.
Let’s Elevate Your Quality System
Whether you’re starting from scratch or upgrading your current system, we support your path to compliance and operational excellence.