Medical device manufacturers are always working to balance the demands of meeting regulatory requirements and also a production cost, in order to produce the most reliable and safest medical devices.
A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and company from day one. In current scenario the regulatory bodies have become more stringent in there process to eradicate non-compliant medical devices companies in the market, hence to ensure an organization is completely compliant with requirements of regulatory suggested to have strong quality management system/ ISO 13485.
Benefits of ISO 13485 to improve the quality of medical equipment
- Improve your company’s credibility and image
- Improve customer satisfaction
- Improve your processes
- Improve decision-making
- Create a culture of continual improvement
- Better employee engagement
- Expanded market access
Qualitcert cert helps an organization to achieve ISO 13485 Quality Management System-Medical Devices by implementing all the required procedure. ISO 17025 is for testing and calibrating labs and equipment’s to check their quality. Qualitcert provides ISO 13485 certification in Saudi Arabia, Oman, Qatar, UAE, Jordan, and Lebanon.
