Top 10 Medical Device Quality Management System Requirements for Regulatory Compliance

The Quality Management System (QMS) is like the guardian of quality in the medical device industry, ensuring that products are safe, effective, and meet all the necessary standards and requirements. 

There are many quality management system requirements to ensure the safety and well-being of patients. Regulatory compliance is a key component of QMS to enhance the credibility of medical devices in the market by fostering trust among healthcare professionals, regulators, and the general public.  

Definition of Medical Device QMS 

To look deeply into medical device QMS requirements let’s start with the definition. A medical device QMS is a structured set of processes, procedures and responsibilities designed to ensure that the development, production and distribution of medical devices meet strict quality standards and regulatory requirements.

By implementing a medical device QMS, manufacturers demonstrate their ability to provide high-quality medical devices and related services while meeting regulatory standards and ensuring patient safety.

A well-established QMS provides a comprehensive approach to maintaining the safety, effectiveness and overall quality of medical devices throughout their life cycle. Ensuring safety, efficiency and compliance can be achieved through various functions, tools and processes implemented in a medical device QMS.

What does it mean to ensure security? Simply put, it helps identify and correct any possible problems associated with medical devices, ensuring that they are safe for people to use. 

To ensure everything works well, QMS makes sure that when companies design, manufacture and distribute medical devices, they do so in a way that always produces good quality products that work as they should.

Compliance with the rules is critical. The QMS ensures that medical devices comply with all necessary rules and regulations. This is not only important for the correct execution of actions, but in some cases, it is a legal requirement. Failure to comply can result in serious consequences, including product recalls, financial losses, lawsuits and reputational damage.

Overview of Regulatory Landscape

National regulatory authorities preside over medical device market authorizations around the world. Their job is to ensure that medical devices that enter the market are safe and efficient and that they continue to meet safety, quality, and performance requirements during their lifetime in the market.

The FDA (US) is a most well-known regulatory body for medical devices. In the EU, manufacturers are regulated at the level of EU member states. There are countless more regulatory agencies are equally important, such as Health Canada, the Therapeutic Goods Administration (TGA) in Australia, and the National Medical Products Administration (NMPA) in China.

There are also the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). As the names suggest, these organizations set standards for the medical devices industry. Some of the important standards in the medical device industry are ISO 13485, ISO 14971, IEC 62304, and IEC 60601-1-12:2014/AMD 1:2020.

Top 10 Medical Device Quality Management System Requirements 

The rule of thumb is that QMS requirements apply to organizations regardless of their size and type unless specifically stated. However, the size and type of organization, as well as the nature of medical devices, may influence the specific nuances of the QMS. Regardless of these variables, all medical device QMS implementations must meet fundamental requirements such as those established below.

Detailed Exploration of Each Requirement

Let's discuss the fundamental requirements that will benefit every manufacturer in more detail.

Documentation requirements

Documentation serves a crucial purpose - it defines processes and provides a record to demonstrate their adherence. Rather than being a source of burden, effective documentation should be about creating a clear path for the team to follow in designing, developing, manufacturing, and supporting medical devices. 

Keeping documents organized and up-to-date is like having a reliable GPS for quality processes. It ensures everyone in the team is on the same page, and the path forward is clear.

QMS documentation required by ISO 13485 includes quality manual, responsibilities and authorities, medical device files, procedures for document control, procedures for design and development, procedures for validation, and more.

To meet compliance with documentation control:

• Use a central document hub

• Clearly define document processes

• Regularly review and update procedures, work instructions, and documents

• Train your team on documentation procedures

Management responsibility

Top management takes center stage and has the responsibility of ensuring that QMS is effective.

First, top management must create and communicate the Quality Policy. This document defines the intentions of the QMS and provides direction to the organization on how medical devices will be created and delivered to customers.

Through the establishment of objectives, top management defines the direction the QMS will take to meet the outlined requirements. Objectives also serve as clear measures of the system's effectiveness, guiding the organization towards continuous improvement.

Appointing a management representative with the authority to oversee QMS efforts is key.

Further, top management is responsible for ensuring that all necessary resources are allocated. Adequate resources are essential for the success of the QMS, and top management's tangible support is crucial to prevent redirection of resources to other projects. 

Management reviews serve as the final check to assess the effectiveness of the QMS and identify areas for improvement. It's like a health check for the system, showing that management is committed to making things better. 

When the mentioned responsibilities above are fulfilled, top management demonstrates that the QMS is an integral part of the organization's business processes. This commitment ensures that the QMS is well-supported, effective, and aligned with the overall objectives of the company.

Design and development controls

The design and development should be a continuation of customer needs and requirements.

Within the framework of ISO 13485, the design and development process include several steps: 

• Design and development planning means setting the stage for the creative process.

• Inputs and outputs mean gathering elements and producing tangible results.

• Reviews, verification, and validation means checking and validating to ensure alignment with criteria.

• Transfer and control of changes means ensuring a smooth transition and maintaining control over modifications.

• Documentation and files mean creating a comprehensive audit trail for future reference.

Notably, the design and development processes under ISO 13485 align with FDA design control regulations in 21 CFR Part 820.30. 

Practical strategies for compliance may include: 

• Design review processes - establishing structured checkpoints.

• Risk assessment during design - identifying and mitigating potential risks.

• Documentation and control - maintaining a clear audit trail of changes.

• Encouraging collaboration - fostering cross-functional teamwork in the design process.

Supplier quality management

The art of supplier management is to get good-quality materials, components or services by establishing effective processes for selecting, evaluating, and managing suppliers. Supplier criteria should be risk-based. 

The following questions aid in establishing such criteria: 

• Does the supplier have the capability to meet specified standards? This question ensures that suppliers can consistently fulfil the requirements.

• How effectively does the supplier perform? Continuous assessment is crucial to assess and maintain supplier effectiveness over time.

• What influence do purchased goods have on overall product quality? Recognizing this impact is essential for maintaining high product standards.

• Are potential risks associated with purchased items thoroughly evaluated? Identifying and managing risks associated with suppliers and their products is crucial.

• Is the supplier critical or minor? Assessing the significance of purchased goods within the context of the entire medical device helps prioritize and focus efforts on critical components.

Practical strategies for compliance may include:

• Setting strict supplier criteria by clearly defining and communicating the standards expected from suppliers is foundational to quality assurance.

• Regular supplier audits by conducting periodic audits ensure ongoing compliance and provide insights for continuous improvement.

• Clear communication with suppliers. Transparent and effective communication helps in building strong relationships and addressing issues promptly.

• Implementing a process for supplier improvements by establishing a structured process for identifying and implementing improvements with suppliers contributes to long-term success.

Production and process controls

The importance of production and service provision aligns with the principles of quality management.  

The purpose of production and service provision is to ensure that the manufacturing of your medical device is planned, executed, monitored, and controlled. Ensuring that manufacturing processes are well-planned is crucial for maintaining product quality, consistency, and compliance with regulatory standards. 

Enhanced product consistency, reduced defects, and adherence to regulatory requirements contributing to patient safety and regulatory compliance will benefit any company. 

Practical strategies for compliance may include:

• Implement in-process inspections. Develop standardized inspection checklists and procedures, train personnel to conduct inspections, and establish criteria for accepting or rejecting products based on inspection results.

• Monitor key process parameters. Utilize advanced monitoring technologies, set up alarms for parameter deviations, and implement automated control systems to maintain optimal conditions.

• Regularly calibrate equipment. Establish a calibration schedule, maintain records of calibration activities, and implement a system for quickly identifying and addressing out-of-specification equipment.

• Have contingency plans for process issues. Conduct risk assessments to identify potential process issues, develop contingency plans for high-risk scenarios, and regularly train personnel on emergency response procedures.

• Check and double-check that your manufacturing processes are reliable and work the way they should.

Risk Management

Risk management is a basic requirement for medical device manufacturers and must be an integral part of the quality management system.

ISO 14971 specifies the necessary process steps and documentation.  

Risk management plan. Product-specific risk management begins with the creation of a dedicated risk management plan which identifies the risk management activities you anticipate and plan throughout the product’s life cycle. It covers the scope of the risk management activities, the identification of the device, intended use, relevant characteristics, defining roles and responsibilities, defining roles and responsibilities, criteria for the product’s risk acceptability, and methods to verify risk control.

Risk analysis. The starting point for identifying specific risks related to medical device products is risk analysis. There are many methods to conduct risk analysis such as preliminary hazards analysis, FMEA, and fault tree analysis. Each of these methods has benefits and drawbacks. 

Risk evaluation. All estimated risks must be evaluated for their acceptability, considering the risk acceptability defined in the risk management plan. The MDR requires all risks to be reduced as far as possible, and risks are only acceptable when outweighed by the benefits.

Risk control. Risks considered unacceptable should undergo appropriate measures for reduction, including inherently safe design, protective measures, and user information. Verification of implemented control measures and consideration of potential negative impacts and potential new risks are crucial. 

Risk re-evaluation. After risk mitigation measures, a re-evaluation of risk acceptability must be performed based on the methods defined in the risk management plan. 

Risk management report. Before market placement, a review of the risk management plan's execution is required, documenting the results in a risk management report. The report assesses overall residual risks and evaluates methods for collecting and evaluating information during production and post-production.

Production and post-production activities. Processes and methods for collecting and reviewing production and post-production data are essential. Data review helps identify hazards, changes in risk acceptability, and actions needed, with documentation of planned and recorded actions.

Risk management is a dynamic process requiring continuous maintenance and updates. Resources should be allocated to update risk management at regular intervals, monitoring trends and safety indications.

Training, competency and employee engagement 

Training, competency and employee engagement are bridging gaps between your team and documentation. Well-trained and engaged teams contribute to maintaining high-quality standards.

Reduced errors and increased efficiency, coupled with a pervasive culture of quality, enhance patient safety and streamline regulatory processes will benefit your company.

To make sure your team knows what they are doing and is engaged in maintaining high-quality standards the following strategy can be applied:

• Develop a comprehensive training program.

• Regularly assess and document employee competencies.

• Foster a culture of continuous learning and improvement.

• Encourage employee involvement in quality initiatives. 

Complaints management

Another requirement for medical device QMS is complaint handling. What is the complaint? Is this customer feedback? Don’t put yourself in a pitfall here.

The main differences between complaints and feedback lie in their nature, formality and intent.  

Complaints are as formal expressions of dissatisfaction related to the performance, quality, or safety of a medical device. On the other hand, feedback is less formal and subjective suggestions that can be either positive or negative.

Specific examples of complaints related to medical devices can be product defects, safety concerns, lack of compatibility, packaging or labelling issues and others. 

Listening to customer complaints and addressing issues promptly builds trust and customer satisfaction. 

Practical strategies for compliance may include:

• Establish a standardized complaint-handling procedure

• Provide training for complaint-handling staff

• Implement a tracking system for timely resolutions

• Use complaint data for continuous improvement

Nonconformance management 

Nonconformance means a situation where a medical device does not meet specified or expected requirements. In simpler terms, it's a deviation from the established standards, regulations, or customer expectations.

ISO 13485 addresses the nonconformance management in a medical device before and even after its use or after its delivery.

Product nonconformance can be triggered by different reasons:

• Specification misalignment refers to the deviation of the medical device from the specified requirements, which could include design specifications, performance criteria, or regulatory standards.

• Regulatory noncompliance occurs when a medical device fails to meet the regulatory requirements set by relevant authorities. This can include safety standards, quality control measures, or industry-specific regulations.

• Customer expectation gap may occur when a medical device doesn't align with customer expectations. This could involve issues related to functionality, appearance, or overall performance.

• Quality standards set by the organization may not be met, leading to nonconformance. This could involve defects, inconsistencies, or other quality-related issues.

Identifying nonconformances in the production or service delivery process is crucial. Early detection allows for timely corrective actions, reducing the impact on subsequent stages and preventing the release of faulty products.

If left unaddressed, nonconformances can escalate, potentially leading to widespread product recalls, customer dissatisfaction, and damage to the brand's reputation. Timely identification and intervention help prevent such escalations.

Learning from nonconformances can lead to enhanced processes, better quality control, and improved overall performance.

Corrective and Preventive Action (CAPA)

CAPA provide companies with a step-by-step approach to dealing with non-conformities. It involves addressing both corrective actions to fix issues that have occurred and preventive actions to avoid potential issues.

We have already explained what is the difference between preventive action, and corrective action and why it is important to use CAPA in our blog series.

Compliance strategies for CAPA may include:

• Implementation of measures to identify, address, and prevent issues, fostering continuous improvement in quality processes.

• Establishing a CAPA process with defined phases of identification, evaluation, investigation, implementation and verification.

• Regularly revision of the effectiveness of CAPA measures and adjust as needed.

Benefits of Compliance

The benefits of regulatory compliance cannot be underestimated. All stakeholders, including patients, expect medical devices to be manufactured to the highest standards.

The main benefits of compliance are as follows:

• Increased patient safety. Compliance with regulatory standards ensures that medical devices meet stringent quality and safety criteria. This directly contributes to improved patient safety, reduced risk of adverse events and improved overall outcomes.

• Simplified regulatory approval. Compliance with regulatory requirements results in a smoother and faster approval process. It ensures that necessary documentation, quality control and safety measures are in place, expediting regulatory approval of medical devices. 

In addition to the already mentioned advantages, the following can be added:

• Operational efficiency

• Risk reduction

• Market and customer trust

• Access to the global market through compliance with international regulatory requirements

• Continuous improvement

• Effective problem solving

Challenges and Solutions

Now you may be wondering how to achieve the benefits for your company. What are the common obstacles or challenges that may arise? What solutions exist for this?

There is no limited list of all possible issues in maintaining compliance. Below are two common challenges and solutions you may consider as you strive for excellence in your medical device development.

Document Management Burden 

Managing a large volume of documents, maintaining version control, and ensuring accessibility can be burdensome, and annoying and lead to postponing your regulatory submission.

To overcome this pain point, a solution such as implementing an electronic Quality Management System (eQMS) to automate document control can be suggested. Train your staff on the use of the system, and regularly review and update documentation.

Product Complexity and Lack of or Poor Traceability

Increasing complexity in the design and features of medical devices always requires more comprehensive and sophisticated traceability systems. It allows to capture of relationships between components, design inputs, and testing criteria.

Traceability plays a crucial role in regulatory compliance, especially during situations like field safety corrective actions (FSCA) or recalls, where quick and accurate identification of affected devices is essential.

To meet regulatory requirements, enhance product safety, and streamline operations you need to build a reliable system offering functionalities to streamline traceability documentation and integration with other aspects of product development.

Medical Device Compliance Success Story

“Theory without practice is empty”. Only knowing regulatory requirements and compliance strategy without taking real action to use proper tools to manage your challenges will not lead to the desired outcomes. 

Let's look at a real-world example where a company overcame the challenges of getting FDA approval for its flagship product.

iCat Solutions was focused on creating innovative medical imaging software. Their product Horos MD provides advanced 3-D views of anatomical details to aid clinicians in diagnosis.

The small software development team faced a significant burden in documenting and managing the quality management and application lifecycle processes required for FDA approval. Manual updates across multiple locations for documentation were inefficient and unsustainable. 

iCat engaged consultants to assist in developing rigorous quality management processes for ISO 13485 and achieving FDA approval. iCat Solutions adopted MatrixALM for centralized application lifecycle management to automate and streamline processes and replaced manual documentation processes with integrated MatrixALM and MatrixQMS solutions. 

As a result, the company significantly reduced the time required for FDA submission documentation. It took only 2 months from implementation to the first FDA submission. Moreover, MatrixALM and MatrixQMS ensured embedded best practices, adhering to ISO 13485 with templates for FDA eSTAR submission.

The result was not only FDA approval for Horos MD but also increased efficiency, reduced administrative burden, and improved focus on core development tasks, ultimately benefiting patient care.

You also can read other success stories of QMS compliance we posted.

Key Takeaways 

• Regulatory compliance is crucial for the medical device industry, ensuring products meet safety standards

• QMS enhances safety, efficiency, and compliance throughout the product lifecycle.

• Understanding the top QMS requirements helps a company choose the best strategy and tools for medical device development. 

• Regulatory approval of your medical device can be achieved faster by implementing a robust quality management system. 

• Overall, compliance leads to increased patient safety, simplified regulatory approval, operational efficiency, risk reduction, market and customer trust, continuous improvement, and effective problem-solving.

By prioritizing regulatory compliance in the medical device industry and implementing robust QMS practices, you can ensure the safety, efficacy, and credibility of medical devices, contributing to the advancement of healthcare and patient well-being.

We are happy to support in you in setting up your beneficial medical device QMS. Don’t hesitate to schedule a demo and test regulatory compliance options for your medical device.