Quality Management System

What Is Management System Certification for Medical Devices?

Management System Certification for medical devices validates that your organisation’s processes are in compliance with regulatory standards, helping to minimise risk, boost product quality, and maintain a high level of patient safety. This certification scope is broad and can apply to:

• Organisations involved in any stage of a medical device’s lifecycle, including design, development, production, storage, distribution, installation, servicing, and final deinstallation.
• Providers or external parties that supply medical device products or services to these organisations.

At Applus+ Laboratories, we specialise in evaluating and certifying these management systems, ensuring that your processes align with the best practices and legal requirements of the medical device industry.

What Is the Purpose of a Quality Management System for Medical Devices?

A Quality Management System (QMS) for medical devices is designed to ensure that organisations consistently provide products and services that meet customer expectations, comply with relevant regulatory requirements, and maintain the highest standards of patient safety. The core purpose of implementing a QMS includes:

• Ensuring regulatory compliance and avoiding legal nonconformities.
• Enhancing product reliability and quality throughout the device lifecycle.
• Reducing risks associated with device failures and protecting patient safety.
• Improving organisational efficiency and reducing operational costs through streamlined processes.
• Increasing stakeholder confidence by demonstrating a robust commitment to quality.

By clearly defining processes, roles, and responsibilities, a QMS enables organisations to maintain control and oversight, ensuring continuous improvement and market readiness.

What Is the ISO 13485 Certification?

The ISO 13485 standard is internationally recognised and focuses on quality management requirements specific to the medical device sector. Obtaining the ISO 13485 certification demonstrates that your organisation has established:

• Compliance with all applicable legal requirements
• Adherence to customer requirements
• Fulfilment of internal organisational standards
• Alignment with medical device technical specifications

By achieving this certification, you not only showcase regulatory compliance but also reinforce confidence in your capabilities to deliver safe, reliable, and high-quality medical devices.

What Are the Benefits of System Certification for Medical Devices?

System Certification under standards like ISO 13485 can bring significant advantages to your organisation:

• Compliance with international regulatory frameworks: Ensures your devices meet global market standards.
• Meeting customer requirements: Demonstrates your commitment to delivering high-quality solutions.
• Complete lifecycle control: Allows you to monitor and manage the specific lifecycle stages.
• Enhanced recognition and trust: Builds credibility and confidence in your organisation within the medical device industry.
• Wider market access: Opens doors to both national and international markets.
• Increased efficiency: Streamlines processes, reducing waste and operational costs.
• Greater stakeholder confidence: Reassures clients and partners that your organisation follows robust quality practices.

Why Choose Applus+ Laboratories for System Certification?

Applus+ Laboratories is an independent, globally recognised body dedicated to helping organisations achieve their commitment to continuous improvement. Our approach is underpinned by:

• Expert Auditors: We align our auditing teams to match each client’s specific sector, ensuring in-depth knowledge and relevant expertise.
• Tailored Certification Plans: Our teams develop customised plans based on your organisational structure, processes, and activities, providing maximum value and streamlined certification.
• International Presence: With a global footprint, we can deliver seamless services to organisations looking to expand into different markets.
• Extensive Portfolio and Accreditations: Our wide range of accredited services allows us to offer a comprehensive solution, from product testing to system certification, all under one roof.

By partnering with Applus+ Laboratories for your Management System Certification, you gain access to a global, expert, and highly specialised team ready to support your organisation’s commitment to safe, high-quality medical devices.