ISO 13485: Quality Management System for Medical Device Manufacturing
How can you ensure your medical devices comply with global regulatory requirements?
ISO 13485 is the premier standard for the medical device industry, ensuring all devices comply with regulatory requirements and meet customer needs. MasterControl's quality management system (QMS) software is crafted by medical device experts. By implementing MasterControl, you'll seamlessly address and comply with many ISO 13485 requirements through its integrated workflows..
- Lower the Costs of Quality and Poor Quality
- Develop a Strong and Resilient Supply Chain
- Strengthen Your Corporate Brand
- Boost Customer Loyalty, Retention, and Sales
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Better Than New – Remanufacturing With Quality at Northeast Scientific
Northeast Scientific is a market leader in high-end peripheral vascular catheter remanufacturing. The intense regulatory scrutiny on their processes makes it important that the production and quality departments work in sync. See how they use MasterControl’s Quality Excellence software to maintain high levels of quality while getting their products back into doctors’ hands as soon as possible.
I like the ease of use of MasterControl for developing batch records. The MasterControl Quality Excellence solution will also verify training at every step in the batch record if you want.
Learn More about MasterControl's QMS Software
ISO 13485 Requirements: FAQ About the Top Medical Device Quality Management Standard
Why Pharma and Medtech Should Digitize Quality in a Down Market
Applying Quality System Regulation (QSR) Best Practices to Improve Regulatory Compliance
Ensure Continuous Compliance With Quality Regulations
To meet both 21 CFR 820 and ISO 13485 compliance requirements, medical device manufacturers must enhance their quality management competencies. These include document control, corrective action/preventive action (CAPA), change control, training, audits, etc. A modern software solution like MasterControl Quality Excellence can help you turn these competencies into competitive differentiators.
Easily Comply With 21 CFR 820 and ISO 13485 Requirements
Make quality a differentiator in ensuring compliance with ISO 13485 standards and the 21 CFR 820 requirements. Get products approved and on the market faster. A digital quality management system like MasterControl Quality Excellence, automates your quality tasks throughout the product’s life cycle.
Contact UsNeed more information about our Quality Excellence system?
Contact us today to find out how MasterControl solutions can streamline your quality management processes.
