ISO 13485 Benefits of Certification
For manufacturers of medical devices who want to provide safe/effective equipment, a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements. Since 2003 when ISO 13485 was first implemented and recognized by the Global Harmonization Task Force, it has quickly become the model standard for the medical industry.
By becoming certified in the ISO 13485 standard your company will:
- Increase the probability of making safe and effective medical devices
- Meet regulatory requirements
- Meet customer expectations
- Help monitor the effectiveness of your supply chain
This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard. With ISO 13485 certification you will be able to enter any major market around the world with one audit!
By becoming ISO 13485 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.
Additional Benefits of ISO 13485 certification:
- Increased Efficiency
- Cost Savings
- More Effective Risk Management and Quality Assurance
- Improved ability to respond to Customer Requirements
How can Consultants - India help you to achieve ISO 13485 Certification?
Consultants - India will assist your organization in SA 8000 awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485 standard. Consultants - India is a result oriented professional training and certification service providers, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity by offering systematic approaches. Our main objective is to help you and your organization improve profitability, through better utilization of all of your resources.
