The International Standard ISO 13485 provides a process based model for a regulated environment with a concept of Plan-Do-Check-Act and is more prescriptive in nature which gives assurance to stakeholders on strong implementation of documented Quality Management System and compliances to applicable National and International Regulatory requirements.
Medical Device(s) includes instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings.
By implementing ISO 13485 , Organization demonstrates its control over highly regulated and safe environment of their facilities directly related to medical device(s) life-cycle, meeting national and international regulatory compliances.
ISO 13485 certification support organizations to meet the International standard of Products and Service they provide, Benefits of ISO 13485 certification are:
We’ll be delighted to quote you for our ISO services.
Please complete the form below and we’ll contact you by the end of the next working day to discuss providing a quote tailored to your needs.