CASE STUDY:

JiT (Just in Time) Certification for ISO 13485

ISO 13485 is the recognized Quality Management System (QMS) standard for regulated medical device manufacturing environments. It is also the quality management system standard harmonized by the European Commission as the basis for CE marking for the three medical device directives; Medical Devices Directive (MDD), In-vitro Diagnostic Devices (IVD) and Active Implantable Devices. ISO 13485 supports quality management in the design, development, production, installation, and delivery of medical devices that are safe for their intended use.

Compliance to ISO 13485 is part of the medical device regulatory framework in most markets including the European Union, United States, Canada, Japan, and Taiwan. ISO 13485 is also central to Health Canada’s Canadian Medical Device Regulations CMDCAS program.

ECM is dedicated to making ISO 13485 certification as simple as possible. ECM offers a complete range of testing, certification and auditing services to manufacturers of medical devices, helping them to manage risks and to ensure the health and safety of patients and users.

With a responsive client service and a flexible approach, we work with you to make the process of ISO 13485 certification as efficient and beneficial as possible.