ISO 13485

All articles tagged “ISO 13485”.

Combining ISO 13485 and ISO 14644 in an Audit

Combining ISO 13485 and ISO 14644 in an Audit

Factory Audits/Management Systems
ISO 13485 and ISO 14644 are key standards that govern quality management systems and controlled environment conditions, respectively. While ISO 13485 focuses on the overall quality management and consistency of medical devices, ISO 14644 specifies the requirements for maintaining cleanroom environments essential for product manufacturing. Combining these standards in an audit provides a comprehensive framework […]
Managing Supplier Quality in ISO 13485

Managing Supplier Quality in ISO 13485

Medical Devices/Supplier Management
In today’s medical device market, ensuring high-quality products and services is crucial for a competitive edge. This is especially true for companies operating in the medical device industry, where product quality directly impacts patient safety and regulatory compliance. To achieve and maintain stringent safety and effectiveness standards, companies often turn to internationally recognized frameworks like […]
What is Medical Device Single Audit Program (MDSAP)?

What is Medical Device Single Audit Program (MDSAP)?

Factory Audits
Medical Device Single Audit Program (MDSAP) An MDSAP is a type of audit that focuses on the medical device industry. It is a voluntary program that helps companies to improve their quality management systems and comply with international standards. The program is based on ISO 13485. What is MDSAP? The Medical Device Single Audit Program […]
Pro QC Attendance – 5th Annual European Medical Device & Diagnostic Quality Assurance Conference

Pro QC Attendance – 5th Annual European Medical Device & Diagnostic Quality Assurance Conference

Medical Devices
The modern medical device industry has transformed global healthcare for one single reason: new technologies enable more accurate diagnoses. However, to be effective, every part that goes into a medical device must be of the highest, fully functional, quality to help ensure patients ultimately receive the right treatment for their concerns. To participate in the […]
Understanding Medical Device Audits and Audit Reports

Understanding Medical Device Audits and Audit Reports

Medical Devices
Pro QC International partners with clients with ease and shares in their success. The medical device industry must produce safe and effective products to diagnose and treat disease. Each year, industry requirements become more stringent as regulatory bodies, standards organizations, and patients expect more in safety and effectiveness. To help device manufacturers meet these ever-increasing […]
Five Things You Should Know About ISO 13485

Five Things You Should Know About ISO 13485

Medical Devices
By The Pro QC Quality Assurance Team 1. What is ISO 13485? ISO 13485 is the global international standard for establishment and maintenance of a documented quality management system in the medical device industry. If a manufacturer has implemented ISO 13485, it will have a foundation upon which to certify for regional medical device regulations […]