Act. In the European Union, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) provide the necessary guidelines. The UK follows similar regulations post-Brexit.

Objectives: Familiarize yourself with the relevant regulations and guidelines applicable to your products.

Documentation: Maintain a regulatory requirements matrix that outlines the applicable regulations, standards, and guidance documents, such as:

• FDA 21 CFR Part 820 (Quality System Regulation)
• ISO 13485:2016 (Quality Management Systems for Medical Devices)
• EMA guidelines for combination products

Roles: Quality managers and regulatory affairs professionals should collaborate to ensure a comprehensive understanding of the regulatory landscape.

Inspection Expectations: Inspectors will review your regulatory requirements matrix to ensure compliance with applicable regulations.

Step 2: Defining the QMS Scope

Defining the scope of your QMS is crucial for ensuring that all relevant processes are included. The scope should encompass all activities related to the design, development, manufacturing, and distribution of your medical devices and combination products.

Objectives: Clearly define the boundaries of your QMS to include all relevant processes and departments.

Documentation: Develop a scope statement that outlines the boundaries of the QMS, including:

• Products covered
• Processes included
• Locations involved

Roles: Quality managers should lead the scope definition process, involving key stakeholders from various departments.

Inspection Expectations: Inspectors will verify that the scope statement accurately reflects the operations and processes of the organization.

Step 3: Establishing QMS Policies and Objectives

Once the scope is defined, the next step is to establish QMS policies and objectives. These should align with the organization’s strategic goals and regulatory requirements.

Objectives: Develop policies that reflect the organization’s commitment to quality and compliance.

Documentation: Create a quality policy document that includes:

• Commitment to compliance with regulatory requirements
• Continuous improvement objectives
• Customer satisfaction goals

Roles: Senior management should be involved in the development of the quality policy to ensure alignment with organizational goals.

Inspection Expectations: Inspectors will assess the quality policy for clarity, relevance, and alignment with regulatory requirements.

Step 4: Developing QMS Procedures

The next phase involves developing detailed procedures that outline how the QMS will be implemented. These procedures should cover all aspects of the QMS, including document control, design control, production and process control, and corrective and preventive actions (CAPA).

Objectives: Ensure that all QMS processes are documented and standardized.

Documentation: Develop standard operating procedures (SOPs) for each key process, including:

• Document control procedures
• Design control procedures
• Production and process control procedures
• CAPA procedures

Roles: Quality managers should lead the development of SOPs, with input from relevant departments.

Inspection Expectations: Inspectors will review SOPs to ensure they are comprehensive, up-to-date, and effectively implemented.

Step 5: Implementing Training Programs

Training is a critical component of an effective QMS. All employees must be trained on the QMS policies and procedures relevant to their roles to ensure compliance and quality.

Objectives: Ensure that all employees understand their responsibilities within the QMS.

Documentation: Develop a training program that includes:

• Training materials
• Training schedules
• Records of training completion

Roles: Quality managers should coordinate training efforts, while department heads are responsible for ensuring their teams are trained.

Inspection Expectations: Inspectors will review training records to ensure that employees have received appropriate training.

Step 6: Conducting Internal Audits

Internal audits are essential for assessing the effectiveness of the QMS and identifying areas for improvement. Regular audits help ensure compliance with regulatory requirements and internal policies.

Objectives: Evaluate the effectiveness of the QMS and identify non-conformities.

Documentation: Develop an internal audit plan that includes:

• Audit schedule
• Audit checklists
• Audit reports

Roles: Quality managers should oversee the internal audit process, while trained auditors conduct the audits.

Inspection Expectations: Inspectors will review internal audit reports to assess the effectiveness of the QMS and the organization’s commitment to continuous improvement.

Step 7: Managing Non-Conformities and CAPA

Managing non-conformities and implementing corrective and preventive actions (CAPA) is crucial for maintaining compliance and improving the QMS. A structured approach to CAPA helps address issues effectively and prevent recurrence.

Objectives: Identify, investigate, and resolve non-conformities to improve the QMS.

Documentation: Develop a CAPA procedure that includes:

• Identification of non-conformities
• Investigation processes
• Implementation of corrective actions
• Monitoring and verification of effectiveness

Roles: Quality managers should lead the CAPA process, involving cross-functional teams as necessary.

Inspection Expectations: Inspectors will review CAPA records to ensure that non-conformities are effectively managed and resolved.

Step 8: Continuous Improvement and Management Review

The final step in establishing a combined and companion QMS is to implement a framework for continuous improvement and conduct regular management reviews. Continuous improvement is essential for maintaining compliance and enhancing product quality.

Objectives: Foster a culture of continuous improvement within the organization.

Documentation: Develop a continuous improvement plan that includes:

• Key performance indicators (KPIs)
• Management review meeting agendas
• Records of management review outcomes

Roles: Senior management should be actively involved in management reviews, while quality managers facilitate the process.

Inspection Expectations: Inspectors will evaluate the organization’s commitment to continuous improvement and the effectiveness of management reviews.

Conclusion

Establishing a combined and companion QMS for medical devices and combination products is a complex but essential process for ensuring compliance with regulatory requirements and maintaining product quality. By following these step-by-step guidelines, quality managers and regulatory affairs professionals can develop an effective QMS that meets the expectations of the FDA, EMA, and ISO standards.

For further information on regulatory requirements, consult the FDA and EMA websites for the latest guidelines and updates.