Assuring Excellence in Medical Device Quality
At QMet, we understand that quality in medical devices is not just a goal but a mandate. It encompasses a commitment to stringent standards and best practices throughout the device’s lifecycle. Here’s how we define it:
Safety and Effectiveness: The Cornerstones of Quality
Quality Assurance: We ensure that our medical devices are safe, dependable, and perform as intended.
Comprehensive Testing: Through rigorous testing and validation, we adhere to the highest regulatory standards, contributing to superior healthcare outcomes.
These FDA regulations are the foundation upon which we build our commitment to regulatory compliance and high-quality standards, ensuring that every medical device we produce at QMet is synonymous with trust and excellence.
At QMet, we proudly adhere to ISO 13485, the international standard that epitomizes excellence in the medical device industry. This standard meticulously covers the full spectrum of a medical device’s life cycle, including:
Design & Development: Crafting devices with precision and foresight.
Production: Manufacturing with cutting-edge technology and unwavering quality.
Installation: Ensuring flawless setup for optimal functionality.
Servicing: Providing comprehensive support to maintain device integrity.
Our unwavering objective is to guarantee that every medical device we produce is not only safe but also performs effectively for its intended purpose. By aligning with ISO 13485, QMet demonstrates its commitment to the highest quality standards, ensuring that patient safety and product efficacy are always at the forefront of our operations.
In March 2016, the latest revision of ISO 13485 for medical devices was released, bringing forth pivotal updates. These enhancements included a more pronounced concentration on managing risks, a more explicit assignment of management roles and training duties, upgraded standards for facilities, improved congruence between design and development criteria with assorted regulations, an intensified focus on overseeing suppliers, defined protocols for ensuring traceability, the incorporation of complaint management processes, and elevated standards for the cleanliness of products.
The ISO standard provides a comprehensive set of criteria for a Quality Management System (QMS) that proves an organization’s ability to consistently produce medical devices that satisfy both customer expectations and regulatory requirements. Concurrently, EN ISO 13485 is tailored for the European Union (EU), establishing a QMS framework specifically for the EU’s medical device sector. Both standards are congruent in their stipulations, with EN ISO 13485:2016 encompassing the entirety of ISO 13485:2016. The distinction lies in the European variant (EN ISO 13485), which incorporates informative tables correlating the ISO 13485:2016 standards with three EU medical device directives (EU directive 90/385/EEC, EU directive 93/42/EEC, and EU directive 98/79/EC). These tables serve as a guide for how adherence to ISO 13485:2016 can help fulfill these EU directives. With the introduction of the European Union Medical Device Regulation (EU MDR) in May 2017, which replaces the earlier directives, it is expected that an updated version of EN ISO 13485 will be released to reflect a closer alignment with the EU MDR.
As of May 2021, the European Union Medical Device Regulation (EU MDR) 2017/745 became active, replacing the previous Medical Device Directive (MDD). This revised regulation introduces a comprehensive and clear structure that evolves in response to new technological innovations, changes in medical knowledge, and updates in law. Importantly, a grace period for specific devices is in place until 2028. Adherence to the fresh MDR stipulations is critical for maintaining market access within Europe.
QMet: Your Trusted Certification Partner: At QMet, we take pride in our track record of certifying a wide range of organizations. Our portfolio includes esteemed entities such as STC, Saudi Investment Bank, Salaam, and TABADUL (Saudi e-Tabadul).
Adaptable Certification Solutions with QMet
At QMet, we understand that businesses are dynamic entities. They grow, evolve, and change shape. Whether it’s the addition of new locations, the introduction of novel activities, or changes in staff numbers, rest assured, we’re equipped to support you through every transition.
Our commitment is to provide flexible certification solutions tailored to your evolving business landscape. We offer adaptable options to modify your scope, standards, and management system, ensuring they remain in perfect sync with your operational needs.
Honesty is the cornerstone of our partnership. We ask that you keep us informed of any changes as they occur. This transparency allows us to maintain a collaborative partnership, where certification is a seamless aspect of your business growth, not a hurdle to overcome.
ISO 13485 is designed for organizations involved in
QMet: Pioneers in Certification and Quality Excellence
QMet stands as a beacon of certification excellence, with a rich history of involvement in a diverse array of management system certifications, inspections, calibrations, testing, and personnel qualifications. Our journey towards accreditation is in full swing, aligning with esteemed bodies such as the Gulf Accreditation Center, Saudi Accreditation Center, SASO, Saber, and SFDA. This strategic move is in accordance with the standards set by the International Accreditation Forum and the International Laboratory Accreditation Cooperation. Since our inception in 2005, QMet has been at the forefront of industry innovation. Our dedicated team has consistently demonstrated an unparalleled ability to grasp the intricate needs of the industry, crafting reliable and robust solutions that cater to a wide spectrum of requirements.