CQ Guide: Gearing up to comply with Quality Management System Regulation (QMSR)? Here’s a quick set of guidelines. 

Medical Device Design & Development

The design and development of medical devices is a resource- and time-intensive process given the sensitive nature of the products. It's a journey of experimentation, research, and trial-and-error, combined with deep engineering and product management expertise.

Adding to the complexity are the varying regulatory requirements (of several regulatory bodies) in different parts of the world. To simplify this process and to unify the regulatory approach, international regulatory bodies have tried to minimize the differences and harmonize the needs.

QMSR Regulations

As part of this harmonization process, the US-based Food and Drug Administration (FDA) released a proposed rule for a new Quality Management System Regulation (QMSR) on February 23, 2022. The idea was mooted in 2018 itself but received a setback due to the COVID-19 pandemic which diverted the attention to introducing protocols to contain the spread of the disease. Now that the threat has been reduced, FDA is back to speeding the harmonization process. 

With the proposed QMSR, the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) will be aligned closely with ISO 13485:2016, the internationally accepted standard for medical device quality management systems. The process will begin in March this year and is expected to be ready for implementation in a year’s time.

The Need for Harmonization

FDA’s QSR and ISO 13485 were first published around the same time in 1996. But, while ISO 13485 has been revised five times till now, the QSR has remained more or less the same. The alignment with ISO 13485 is expected to make FDA regulations on par with the internationally accepted regulatory expectations for QMS for devices but will continue to be under the FDA jurisdiction.

Benefits of ISO 13485

The ISO 13485 standard enables medical device manufacturers to incorporate best practices for manufacturing by establishing a set of interrelated requirements to create a Quality Management System. Implementing ISO 13485 can help medical device manufacturers maintain medical-grade quality, improve customer satisfaction, and achieve continual improvement.

By getting certified for this regulation, entry into international markets and customer acquisition will become easier. This standard is also recognized by the EU, thereby reducing the burden on US manufacturers to comply with the EU MDR QMS requirements.

ISO 13485 implementation will help manufacturers produce high-quality and safe products. They will gain insights into potential risks during the product development process, enabling them to proactively address and correct them. It will also improve inspection and traceability measures for all medical devices.

This standard also emphasizes the importance of setting up specialized processes for sterile medical devices and strict adherence to cleanliness requirements.

Harmonizing QSR with ISO 13845

In the current revision of 21 CFR Part 820, only the gaps are being addressed and the 2016 revision of ISO 13485 will be the point of reference. By aligning Part 820 with ISO 13485:2016, FDA will also be removing any redundancy or inefficiencies that act as roadblocks for medical device companies in complying with both QSR and ISO 13485. The harmonization will simplify compliance and reduce the burden while ensuring patients with better access to necessary devices.

Regulatory harmonization represents a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products.

Harmonization will enable medical device companies to save anywhere between $439 million and $533 million due to the reduced compliance burden. It will also reduce the burden of compliance in terms of time and resources.

QMSR Vs QSR

According to the FDA, Part 820 and ISO 13485 are already similar in many ways and the changes are not expected to impact the basic QMS requirements for medical device companies. For example, ISO 13485 requires device companies to maintain a medical device file (MDF), which is the same as Part 820’s Device Master Record, which is going to be replaced with MDF. 

Where ISO 13485 terms and definitions are inconsistent with the Federal Food Drug & Cosmetic Act and its implementation, the FDA definitions will supersede. For greater clarity, Section 5, Part B of the proposed rule explains FDA’s stance on harmonization.

Some of the new sections proposed in Part 820 include,

• Section 820.7 - Incorporation by reference
• Section 820.10 - Requirements for a quality management system
• Section 820.15 - Clarification of concepts
• Section 820.35 - Control of records
• Section 820.45 - Device labeling and packaging controls

Some of the other key aspects to note include:

• Clause 7.3 of ISO 13485 on design and development will apply only to manufacturers of some of the listed Class I devices apart from manufacturers of Class II and III devices.
• The traceability requirements of Clause 7.5.9.2 for implantable medical devices would be extended by FDA to cover devices that support or sustain life, as specified by Part 820.65 but not required by ISO 13485.
• FDA will continue to lay stress on the role of the top management with executive responsibility in establishing a culture of quality in the organization.
• Customer is defined in the QMSR as any internal or external user of the product or service who could be an individual or an organization and involved in any part of the device manufacturing process. Therefore, contract manufacturers and component makers are also included in this definition.

FDA’s QSR uses a risk-based approach to quality, but ISO 13485:2016 establishes the requirements more explicitly. Therefore, QMSR will draw heavily from ISO 13485 to stress risk management in design controls.