Change Management
for Medical Devices

What is change management in the medical device industry?

Change management refers to the way a company manages modifications to products and processes within their medical device business. Change can come about for a number of reasons, and we refer to these as triggers for change.

Many events can trigger a change throughout the lifecycle of a product or organizations, including:

1. New or modified products, as well as any subsequent change to those products

2. New or modified processes for how you conduct business as you right-size and grow your QMS

3. New or modified controlled documents, such as templates, work orders, forms, etc., as well as any subsequent revisions made to those documents

New products, processes, or controlled documents all require change management practices be put in place. A change can involve modifications to records and procedures in your design controls, or your device master record (DMR).

You might find yourself needing to do additional validation on a device, or maybe you are changing suppliers, which requires changes to associated documents and procedures.

Medical device companies must establish a change control process to ensure internal consistency throughout their quality management system and documentation.

The purpose of a change control process is to manage changes in the QMS, preserving internal consistency within the system by ensuring that updates to important documents are reflected everywhere those documents are used. The change process should also include an element of approvals, ensuring that major changes to the QMS are reviewed by multiple stakeholders before implementation.

Regardless of where you choose to market your products, your medical device company must establish and maintain a quality management system (QMS) to ensure that they are safe and effective for the end user. Quality management systems undergo constant change throughout the life cycle of your product, and managing that change effectively is one of the most important functions of the QMS.

What steps should be taken during the change control process?

When implementing a change control process, medical device companies need to ensure that they are meeting the change control guidelines as required by the FDA QSR. A formalized change control process ensures that your organization is performing process validations, conducting approvals and producing change records when required. Here's what to include on your change control documentation:

• Identification - The first step to implementing change is identifying the need for change. What needs to be changed? Is it a design change, a document change or a process change?

• Description - Describe the change in detail

• Identification of Affected Documents - What documents are affected by the change? Design changes will affect your technical documentation, device master record, and design dossier. Changes to a manufacturing process might affect your working instructions or SOPs for those processes.

• Signature of Approval - The changes should be authorized by a designated person, usually the quality manager.

• Approval Date - In compliance with the FDA QSR document control requirements, document changes should always be documented with the date of the approval indicated.
• Effective Date - An approved change may or may not take effect immediately.

Medical device companies that effectively monitor the inter-dependencies of documents in their QMS will have an easier time identifying documents that are affected by a change and maintaining consistency within the quality documentation.

What are the change control requirements under FDA QSR?

The FDA quality system regulation (QSR) known as 21 CFR Part 820 makes reference to several types of changes that medical device companies should manage through a formalized change control process:

• Part 820.30(i) Design changes. Manufacturers must establish and maintain procedures for the identification, documentation, validation, review and approval of design changes before they are implemented.
• Part 820.40(b) Document changes. Changes to documents shall be reviewed and approved by a designated individual. Each manufacturer shall maintain records of changes to documents.
• Part 820.70(b) Production and process changes. Manufacturers must establish and maintain procedures for changes to a specification, method, process or procedure. They should be verified, validated or approved when appropriate.
• Part 820.70(i) Automated processes. Software changes shall be validated before approval and issuance.
• Part 820.75(c) Process validation. When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform re-validation when required.
• Part 820.100(a)(5) Corrective and preventive action. Each manufacturer should establish procedures for implementing CAPA, including procedures for implementing and recording changes in methods and procedures needed to correct and prevent quality problems.

What are the change control requirements under EU MDR?

The EU Medical Device Regulation (MDR) covers the requirements specific to design changes in several different contexts, including:

• Article 10(9). Changes in device design […] shall be adequately taken into account in a timely manner.
• Annex VI, part C, 6.5.2 (Software): A new UDI-DI shall be required whenever there is a modification that changes the original performance; the safety or the intended use of the software; interpretation of data. Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.
• Annex IX, 4.10: Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device.

How to get CE Marking after making changes to a device

Obtaining a CE marking certification is a straightforward process, but you'll have to invest time and resources in preparing your company for a third-party audit by a notified body.

Here are the 8 steps you must follow to obtain CE marking certification for your medical device:

1. Determine which EU requirements apply to your device.
2. Determine the classification of your device.
3. Implement a quality management system that is compliant with ISO 13485:2016.
4. Prepare a CE marking technical file or design dossier.
5. Establish a physical location in Europe, or appoint a European representative for your company.
6. Have your QMS and technical file/design dossier audited by a Notified Body, unless exempt.
7. Obtain CE marking and ISO 13485:2016 certificates from the Notified Body.
8. Prepare a Declaration of Conformity (DoC), stating that your device complies with the appropriate directives.

What are the change control requirements under ISO 13485?

ISO 13485:2016, the globally harmonized standard for medical device quality management systems, covers what's required of manufacturers when it comes to the control of design and development changes:

Section 7.3.9. Control of design and development changes. The organization shall document procedures to control design and development changes. The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use.

The requirements are nearly identical as those found in FDA's QSR, whereas prior to implementation all design and development changes shall be:

• Approved; 
• Reviewed; 
• Verified and validated;
• Documented

When reviewing any change, manufacturers should always use a risk-based approach to evaluate the impacts of that change on other quality subsystems and processes.

Manufacturers must produce and maintain records showing proof of all change reviews and activities leading up to final approval and implementation.

Understand and Manage the Impact of Any Change

Greenlight Guru Change Management software enables medical device companies to link or connect any documents or configuration items that are stored in the quality system.

This simplifies the change management process, increasing the visibility of inter-dependencies between change records, documents, risks, design controls, customer complaints, audits, non-conformance reports and more.

When a specific document needs to be changed, Greenlight Guru makes it easy to quickly determine what other documents are affected and automates the approval and record-keeping aspects the change control process.

Halo℠ by Greenlight Guru: The world's first AI and machine learning recommendation engine for medical device quality 

Halo℠ by Greenlight Guru is the first predictive recommendation engine for medical device companies to easily make the shift from reacting to changes to predicting changes.

Intelligent Document Management powered by Halo℠ leverages unique artificial intelligence (AI) and machine learning (ML) technologies to create efficiencies and improve quality across the change management process.

These new capabilities work in tandem with those of Greenlight Guru Visualize to provide medical device companies with a network view of the entire quality system with real-time visibility into the impact of a change on connected policies, procedures, and artifacts in a single, closed-loop quality system environment.

Gain control of your change process by leveraging Greenlight Guru Change Management Software, the only QMS software solution designed exclusively for medical device companies.