2 years ago
May 24, 2017
EC Innovations Receives ISO 13485 Certification for Medical Devices
Chicago, IL – May 10, 2017 – EC Innovations, one of the fastest growing Language Service Providers, recently became ISO 13485:2016 certified for Medical Device and Quality Management Systems. This certification is a requirement for regulatory purposes, an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
The ISO 13485 certification is intended to be used by organizations throughout the lifetime of a medical device, from start to production and post-production. It also covers aspects such as storage, distribution, installation and servicing, and providing associated services. Additionally, the certification can be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
You might wonder how ISO certifications are audited and why a translation company like EC Innovations would get certified. For this, we turned to our Managing Director and Operations Manager of ECI’s Budapest location, Katalin Varga. She helped answer some of our questions as she worked to get EC Innovations certified.
Why did EC Innovations apply for the ISO 13485 certification?
The manufacturing of medical devices and the related services must comply with extremely rigid regulations. Suppliers of this industry, even translation companies, are no exception. We need to pay extra attention to minimize the risk that might derive from medical translation and medical-device localization. By having our internal process certified, we can demonstrate our risk management and corrective/preventive actions that are vital when translating for the life sciences industry.
How long did the process take?
The preparation process took several long weeks. As our processes were reviewed, we applied corrections where needed, and prepared the necessary quality management documentation. The audit was performed by Certop, a leading organization that helps companies achieve various international standards.
How does this help clients?
Our clients in the medical device industry can rely on our processes and integrate our risk management system as a supplier into their current quality management system. This certification is to prove our capability in this field, our overall competency and to show that EC Innovations is a company they can rely on.
How does this set EC Innovations apart from others?
Not only does this certification give ECI a competitive edge, it’s also a tool to help us improve our internal approach when working with similar highly-regulated organizations, helping us become more efficient. Becoming certified for a certain industry accredits EC Innovations as experts in that specific industry. This helps EC Innovations be cautious with certain industries and their regulations as well as keeping us up-to-date with industry standards and compliance regulations.