ISO 13485:2003 - Medical Devices

The design, manufacture and marketing of medical device product is a highly regulated process with strict governmental requirements. There are a number of specific standards and directives including:

ISO 13485:2003

ISO 13485:2003 specifies the requirements for a quality management system applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Medical Device Directive (MDD 93/42/EEC)

The Medical Device Directive was published in 1993 by the European Commission. In June 1998, the Directive became mandatory and medical devices, which fell under the scope of the Medical Device Directive, were no longer allowed without the CE mark on the European market.

In Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC)

The In Vitro Diagnostic Medical Device Directive was published in 1998 by the European Commission. In June 2001, the Directive became mandatory in Ireland.

CE Marking

The CE Mark is a declaration by a manufacturer that a product meets all requirements of the relevant legislation, including those related to product safety. A device bearing the CE Mark can be distributed freely in the EU.

Almir Business Ltd provides a practical and hands on approach to quality management system consultancy. We offer a cost effective and value added focus and bring the knowledge and experience of proven systems. We customize to your unique requirements and work closely with you to meet your needs and budget.

Our approach includes

Gap Analysis - Check the operation of the existing system in place against the requirements of ISO 13485:2003
Development - Establish processes, procedures and the organizational structures necessary for the Quality Management System
Implementation - Put the quality management system into practice
Maintenance - Supporting and improving the quality management system

Highlights

Risk Management – Supporting the development of risk assessment programs
CE Marking – Assist in the preparation of applications and technical documentation associated with Medical Device & OEM registrations.
System Integration - with ISO 9000 Quality Management Systems
Awareness training - ISO 13485, Medical Devices directive & InVitro Diagnostic directive awareness training.
Registration - to ISO 13485 and Registration of Medical Devices

Benefits & Advantages

Ensure regulatory compliance and reduce liability
Competitive marketing advantage
Improve overall performance and reduce costs