ScienceSoft Achieves ISO 13485 Certification for Medical Device and Quality Management Systems
Published:
In March 2018, ScienceSoft attained ISO 13485:2016 certification from PECB – a global provider of certification services. The accreditation proves that ScienceSoft’s quality management system meets most current regulatory requirements specific to the medical device industry. ISO 13485:2016 demonstrates ScienceSoft’s commitment to the highest quality and meeting customer and regulatory expectations. “We are very proud of this achievement, as this opens for us new opportunities in our healthcare IT services – design and development of software for medical devices and related services,” said Nick Kurayev, CEO of ScienceSoft.
A globally recognized international quality standard, ISO 13485:2016 (Medical Devices – Quality Management Systems – Requirements for regulatory purposes) presents strict regulations for the implementation of highly secure and sustainable medical devices. Only those organizations that prove they are consistent in meeting these regulations can qualify for the certification.
Attaining an ISO 13485 certificate officially makes ScienceSoft a trustworthy business partner capable of providing safety, reliability and superior quality in the development of software solutions for medical devices.