ISO 13485 certification for Medical Device Industry – URS India

restrictions. The ISO 13485 certification also tends to motivate the companies to work fairly and achieve
the required organization goal efficiently and effectively.
The ISO 13485 certification for Medical Device is valid for 3 years. The company can renew the
certificate after 3 years. Though it is an international certification for Medical devices, however, the
country can modify the regulations as per their business requirements.
This standard is important for manufacturers, designers, and distributors of medical devices. Suppliers
and service providers can also enhance their respective organizations reach as now more manufacturers
require certification to do business with vendors. Patient safety greatly depends on the quality and
consistency of medical products when it comes to the manufacturers of medical devices. The quality
management system of medical products is critical for patients, customers, regulatory agencies and
stakeholders. The company requires this certification so that they can be able to work worldwide
network with potential customers and business partners. Third-party audited and certified quality
management system preferred by the national and international authority for manufacturers. Investing
in such a certificate will help manufacturers to access the countries in those countries where it requires.