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BMedical Device Management System

ISO 13485 is an international standard that represents the needs for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is based on the ISO 9001:2008 procedure model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory needs.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Benefits of MDD - Quality Management System include

Few of the benefits of implementing MDD - QMS include

  • Ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
  • Reduction of operating costs, decrease of nonconforming products costs, raw materials, energy and other resources savings
  • Simplifying the procedure of attestation of conformity to needs of EU directives and corresponding Government Orders
  • Improving trust of public and public monitoring bodies in respect of the medical devices manufacturer
  • Attestation of efficiency and helpfulness of the established quality management system by a self-governing third party
  • Guarantee of production procedure stability and thus steady and high quality of services and products supplied to clientele
  • Integration of multiple standards ISO 14001, ISO 45001, IATF 16949, AS 9100, etc.)

Consulting Methodology

A proven Quality Management System development and implementation approach should be used based on project management methodologies. A structured approach should be used for defining project plans, specific responsibilities and verification of results. The result will be a development and implementation strategy that is more efficient and provides for first time compliance or registration to the ISO 9001 requirements.

Following phases are involved in development and implementation of an effective Quality Management System

  • Development of Project Plan
  • Review and Gap Assessment
  • c. Process Mapping and Management System Development
  • Management System Implementation
  • Internal Assessment and Management Review

Benefits of QMS Consulting include

Best practices and depth of knowledge and experience significantly impacts the QMS design and ability to meet the organizations’ business goals. An experienced consultant helps your organization live and own the QMS and operate it at its optimal level.

Following can be some of the benefits of having and experienced consultant for development of management system

  • An effective and reliable management system
  • Increased objectivity and impartiality
  • Reduced number of operational process defects
  • Increasing business opportunities
  • Reduced QMS development and implementation time
  • QMS designed to suit the organization and your customers’ requirements