Medical Audit

All articles tagged “Medical Audit”.

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 […]
How to conduct an ISO 13485 Internal Audit Assessment

How to conduct an ISO 13485 Internal Audit Assessment

Medical Devices
Agenda and checklist for a third-party ISO 13485 audit Introduction – ISO 13485 Internal Audit Assessment What is an Internal Audit Assessment? An Internal Audit Assessment is a formal, comprehensive comparison of the current state of an organization’s processes and procedures against a standard or regulation. The analysis will show where the organization is and […]
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 […]
Pro QC Supplier Management Service – From Supplier Identification to End Quality

Pro QC Supplier Management Service – From Supplier Identification to End Quality

Supplier Management
By The Pro QC Quality Assurance Team Part 2 – Supplier Development, Continuous Improvement, Ideal Outcomes Supplier Development In tandem with the creation of a functional supplier, a relationship is effective supplier development. This is essentially a focus on analyzing your supplier’s performance and establishing an action plan to ensure sustained performance, which in turn […]
A Guide to Supplier Management

A Guide to Supplier Management

Supplier Management
By The Pro QC Quality Assurance Team Part 1 – Supplier Identification, Quality Systems Audits & Supplier Relationship Management You’ve already defined your targets in support of your business strategy. You have designed and defined the product specifications that are necessary to fulfill your customer’s needs. Now you just need to find and collaborate with […]