Quality Management for Medical Devices

Quality Management Systems (QMS) for Medical Devices

A Quality Management System (QMS) is a formalized system that documents:

• Processes
• Procedures
• Responsibilities

All aimed at achieving policies and objectives that define the quality of a medical device.

A QMS helps coordinate and direct an organization’s activities to meet regulatory and customer requirements, while continuously improving effectiveness and efficiency.

We provide consulting and support for quality management systems for medical device companies across Europe and the United Kingdom.

Our Services

Our QMS-related services include, but are not limited to:

Implementation & Improvement

• Implementation, audit, and improvement of ISO 9001 and ISO 13485 quality management systems
• System updates and continuous improvement

Additional Standards

• Implementation, audit, and improvement of ISO 22716, BRC, and IFS standards

Audit Preparation

• Preparation for certification audits
• Support in resolving issues and non-conformities following audits or inspections

Supplier Audits

• Qualification and auditing of suppliers

IVD Support

• Specialist support for manufacturers of in vitro diagnostic devices (IVDs)

Focus on ISO 13485

Cost of Implementation

The cost of implementing an ISO 13485-compliant quality management system depends on several factors:

• Size of the organization (number of offices, branches, and employees)
• Scope of the QMS (e.g., development, production, sales, support)
• Existing quality systems (e.g., ISO 9001)
• Level of management commitment and employee involvement

Timeline

The time required to implement an ISO 13485-compliant system varies depending on the organization.

In general:

• Consulting support ranges from approximately 8 to 20 days
• The overall process may take at least 6 months to reach certification

Our Approach

We support organizations throughout the entire QMS lifecycle — from initial assessment and system design to certification and continuous improvement — ensuring full compliance and long-term operational efficiency.