Welcome to Medical Device Management System Consultancy Portal

About MDMS & benefits of consultancy

Consultancy solutions to implement medical device management system for resilient & smarter businesses


ISO 13485 as a world standard determines the wants for the medical devices industry. The standard was designed and established to be employed by companies during the life cycle of medical devices, from production to post-production, including decommission and disposal. However, ISO 13485 also can be operated by other parties like certification bodies which may assist within the certification processes. ISO 13485 is a tool for organizations to develop and retain their processes efficiently. Organizations that are seeking continuous improvement will enjoy this standard by having the ability to supply safe and competent medical devices and achieve the trust of consumers. The requirements needed for this International Standard also can be hired by suppliers or other external parties providing products (e.g., components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services, raw materials) to such organizations. The supplier or external party can voluntarily prefer to conform to the wants of this International Standard or are often required by contract to evolve.

Course details
By becoming an ISO 13485 certified professional, you'll be able to:
Increase the amount of job opportunities
Create new business connections
Gain competitive advantage
Increase effectiveness and lower costs
Offer expertise on improving work processes
Technical information
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and contamination control
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring equipment
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
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