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ISO 13485:2016 | Quality Management Systems for Medical Devices Certification
$7,474.98
ISO 13485:2016 | Quality Management Systems for Medical Devices
- Globally Recognised & Verifiable ISO Certificate on IAF Database.
- Documentation Preparation, Review & Audit.
- 3-Year Validity with Maintenance (surveillance)
- Remote Annual Surveillance Audits.
- Official ISO Certified Logos for Marketing.
- Certification Delivery in 1-5 days.
- Your certificate is updated on IAF database in 20 days (Verifiable on IAF: https://www.iafcertsearch.org)
Description
What is ISO 13485:2016?
ISO 13485 is the internationally recognised standard for quality management systems (QMS) specific to medical devices. First published in 2003 and most recently revised in 2016, the standard outlines the processes, documentation, and controls needed to design, produce, store, distribute, install, and service safe and effective medical devices.
In short, ISO 13485 certification is often the fastest route to prove you meet the minimum regulatory expectations in any major market.
Invest in ISO 13485 today, and protect your patients, your reputation, and your bottom line tomorrow.
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