Harmonise Quality Management to Comply With 21 CFR 820 and ISO 13485
How can you ensure your medical devices comply with global regulatory requirements?
To sell your medical devices worldwide, it’s important to conform to global regulatory requirements. Keeping your quality management system updated with the latest technology trends helps you consistently comply with both 21 CFR 820 and ISO 13485 requirements.
- Learn the differences between 21 CFR 820 and ISO 13485.
- Find out what quality system requirements are essential to satisfy international medical device regulations.
- See how companies ensure that documentation, training, corrective action/preventive action (CAPA), etc. are in compliance.
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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
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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.
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Contact us today to find out how MasterControl solutions can streamline your quality management processes.
