Medical devices — Quality management systems — Requirements for regulatory purposes
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
WHAT IS ISO 13485 FOR?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
CERTIFICATION TO ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
OBJECTIVE
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
BENEFITS
- Improve your company’s credibility and image. ISO 13485 is the internally recognized gold standard for quality in the medical device industry
- Improve your processes
- Improve decision-making
- Create a culture of continual improvement
- Better employee engagement
ADVANTAGES-
1.Suitable for both small and large organizations.
2.Better internal management.
3.Less wastage.
4.Increase in efficiency, productivity and profit.
5.Improved customer retention and acquisition.
6.Consistent outcomes measured and monitored.
7.Globally recognized standard.
Revolutionary Certifications Services provides services for ISO 13485:2016. For more information, email us at info@rcscert.com