Setting up a Quality Management System

Introduction

Setting up a Quality Management System (QMS) that complies with industry standards, guidelines and regulations can be a challenging task for medical startups and emerging innovators. Medace has streamlined this process by setting up a uniform QMS which can be used as a backbone for our clients’ product and QMS development. Moreover, Medace has an experienced team of Quality experts assisting our clients in tailoring their QMS. Thereby providing clients with the necessary tools and knowledge to establish and maintain a tailored QMS.

Discover the key benefits of our QMS services at Medace:

📝 Streamlined Compliance: Our QMS templates are developed in accordance with international standards, guidelines, and regulations. Enabling you to navigate the complex development landscape with a solid backbone in your organization.

🏆 Expert Guidance: Our QMS experts have extensive industry experience and possess in-depth knowledge of quality management systems. They will collaborate closely with you to understand your specific requirements, provide tailored recommendations, and support you at every step of the implementation journey.

🎯 Train your team: The Medace model is based on a work-learning environment. This means that the Medace team works with(in) your team to guide (and teach) you how to develop your product according to the applicable rules and regulations. Our philosophy is that this way of product development is more sustainable than outsourcing because you acquire the knowledge to repeat the process yourself at the end of the learning curve.

Scope

At the heart of Medace’s approach sits our QMS filled with all relevant templates for both Medicinal Product as well as Medical Device trajectories. From Quality Policy to Risk Management SOP and Auditing Plans, our templates are meticulously crafted to meet industry best practices and regulatory requirements. Whether it is ISO 13485 or specific GMP guidelines, Medace’s templates serve as a solid foundation for clients to build their QMS on.

By leveraging our QMS templates, you can save time, reduce complexity, and focus on what truly matters – delivering high-quality products and services to the market.

Tailored support

The guidance and support provided by Medace extend beyond merely implementing ‘’a’’ QMS. We collaborate closely with clients to evaluate their unique products and identify the specific quality and regulatory requirements. Medace’s experts then assist in customizing our QMS templates to suit our clients’ needs, ensuring a seamless integration of quality management practices into their overall business strategy.

From initial consultation and GAP assessments to training courses, documentation and ongoing support, the experts at Medace are committed to ensuring that clients’ QMS’s are not only compliant but also optimized for efficiency and effectiveness.

QMS and facilities

Renting the state-of-the-art labs of Medace, combined with a comprehensive QMS in place, offers significant benefits for companies involved in the development of medical products.

By utilizing Medace’s state-of-the-art labs and cleanrooms, companies gain flexible access to advanced research and development facilities, innovative equipment, and a controlled environment enabling clinical manufacturing. Moreover, with an overarching QMS in place at the facility, companies can leverage a robust framework of SOPs, training courses, work instructions and documentation throughout the product development process. This unique integration of flexible facilities and a proven QMS ensures that companies can focus on their core research and development activities, leading to accelerated development timelines and reduced capital expenses.

Contact our experts today to discover how Medace’s guidance and support can help you establish and maintain a robust QMS that aligns with industry standards and regulations.

Let’s accelerate biomedical innovations, together.