Quality Management System - QMS
Always Ready for Inspection: Expert QMS Solutions for Medical Device and IVD Manufacturers
An effective Quality Management System (QMS) is crucial for the long-term success of medical device, IVD, and company strategies. It prepares you for future challenges, helps in early issue detection, and facilitates planning for necessary changes. Investing in a robust QMS enhances company value and reduces stress for employees, ensuring you are always inspection-ready.
GBA Group QMS Services
- Startups: Build your QMS from scratch.
- Established Companies: Assist with internal audits, GAP analysis, handling non-conformities, enhancing effectiveness, and QA/RA refreshment.
Understanding Regulatory Requirements Across Borders
All companies in the Medical Device and In-vitro Diagnostics markets are required to have a QMS. While ISO 13485:2016 serves as a global baseline, each market has specific requirements.
- Worldwide: ISO 13485:2016 is an international standard for QMS certification, ensuring compliance and serving as a quality stamp.
- Europe (MDR/IVDR Article 10): All companies must comply with MDR and IVDR, regardless of risk class.
- USA: Quality System Regulation (QSR): Medical device companies must comply with 21CFR820. The FDA proposed aligning QSR with ISO 13485:2016 for global consistency and faster market entry. This rule is not yet effective.
- MDSAP: A global initiative for efficient oversight of QMS, involving the USA, Canada, Brazil, Australia, and Japan.
Benefits of QMS
- Increases internal efficiency and maintains improvements.
- Enhances trust among customers, suppliers, and employees, improving profitability.
- Provides structured operations and visible proof of systematic work.
- Maintains knowledge within the company, reducing reliance on specific individuals.
- Reduces risks of extra work and missed tasks.
- Facilitates quick problem identification and informed decision-making.
Exploring the Benefits of eQMS
We offer Focalcube, an easy-to-use and competent cloud solution for quality management provided by Medos. Read more
Explore the full range of our QMS services and see how we can help your company stay ahead. Visit the GBA Key2Compliance website for detailed information and tailored solutions.