Consulting

The ISO 13485 is an internationally recognized standard for Quality Management System for the Medical Devices industry designed to help of manufactures must incorporate into their management systems. The ISO 13485 standard can be used by an organization for the design, development, production, and installation and servicing of medical devices as well as for the design, development and provision of related services.

Stapes for ISO 13485 Certification 

• Gap Analysis                                                                
• Design & Development
• Implementation & Training
• Re-registration Assessment & Management Review
• Certification
• Maintaining and Effective Quality Management System

Advantages of ISO 13485 certification:

As we mentioned, ISO 13485 certification is not mandatory in most markets. Here is how your company can benefit from ISO 13485 certification:

• Compliance with European standards offers straightforward access to the Japanese, Australian and New Zealand markets
• Other countries around the world also recognize ISO 13485 as a means of meeting their quality requirements
• ISO 13485 is a globally recognized standard and having this certification will increase the credibility of your company with potential customers.
• Certification can lead to increased efficiency, better product quality, and improved customer service within your company
• Demonstrate your consumers and partners a commitment to quality