Quality Management for Medical Devices & Combination Products

Kivo QMS FAQs

1. What is a QMS for medical devices and why is it required?

A Quality Management System (QMS) for medical devices is a structured set of policies, procedures, and processes designed to ensure that products meet regulatory requirements and consistently achieve their intended performance. Regulatory bodies like the FDA and ISO require a formal QMS to protect patient safety, maintain product quality, and ensure traceability throughout the device lifecycle. Without a compliant QMS, companies risk delayed approvals, regulatory penalties, and costly recalls.

2. What regulations apply to quality management for medical devices?

Medical device companies must comply with several key regulations, including ISO 13485 (the international standard for medical device quality management) and FDA 21 CFR Part 820 (the Quality System Regulation or QSR for devices sold in the U.S.). Companies that market products globally may also need to meet additional requirements under the EU MDR (Medical Device Regulation) and MDSAP (Medical Device Single Audit Program). Kivo QMS is designed to align with all applicable regulatory frameworks and is also designed to handle the additional complexities of combination products.

3. How do I choose the best QMS software for a medical device company?

When choosing a QMS software for a medical device company, look for a system that is purpose-built for medical device compliance, not simply adapted from general industry standards. Key features should include support for design controls, risk management, document control, CAPAs, audits, training management, and supplier oversight. It’s also critical to select a platform that is Part 11 compliant for electronic records and signatures, offers validation documentation, and can scale as your company grows. Click here to see how Kivo QMS keeps you compliant at a fraction of the cost of legacy systems.

4. When should a medical device startup implement a QMS?

A medical device startup should ideally implement a QMS before beginning formal design and development activities (and typically before starting design controls). Establishing a compliant QMS early helps companies capture required documentation, manage risks, and avoid rework that could delay regulatory submissions like 510(k)s, PMAs, or CE markings. Waiting too long can lead to gaps that are costly and difficult to fix under the pressure of inspections or audits.

5. What features should a medical device QMS include?

A medical device QMS should include core capabilities such as document control, design history file (DHF) management, risk management, change control, CAPA tracking, nonconformance reporting, supplier management, training management, and audit readiness. Advanced QMS platforms also integrate dashboards and reporting tools to provide real-time visibility into compliance activities. For combination products, it’s important that the QMS can support both device and pharma requirements seamlessly. Kivo QMS is a modern solution built to handle these exact needs while providing an easy, intuitive user experience and costing a fraction of the price of legacy systems.

6. How does a QMS help with FDA inspections and ISO audits for medical devices?

A well-structured QMS helps medical device companies stay inspection-ready by ensuring all required records, approvals, and traceability are in place and easily accessible. During an FDA inspection or ISO audit, regulators will review your procedures, training records, design documentation, risk assessments, and CAPA processes. A compliant QMS like Kivo simplifies this process, reducing the risk of findings, warning letters, or certification delays, and helping demonstrate a strong culture of quality to regulators.

7. What are the benefits of using a cloud-based QMS for medical device companies?

For medical device companies, a cloud-based QMS can significantly accelerate inspection readiness, streamline supplier and training oversight, and support faster product development cycles. Cloud-based systems also offer faster implementation, lower upfront costs, and easier scalability as your business grows. Unlike on-premise systems, cloud systems provide real-time access to quality data from anywhere, enabling cross-functional teams to collaborate seamlessly across locations. They also reduce the burden of maintaining validation and security internally, as reputable vendors deliver pre-validated updates and handle infrastructure compliance.

8. How does a QMS handle CAPAs, deviations, and audit trails?

Kivo QMS provides structured workflows to manage CAPAs (Corrective and Preventive Actions), deviations, and audit trails in a compliant, traceable way. When a deviation or nonconformance is reported, the QMS routes it through predefined steps for investigation, root cause analysis, corrective action planning, and effectiveness checks. CAPAs can be linked directly to related deviations, audit findings, or risk assessments, creating a fully traceable chain of quality events.
Kivo QMS also automatically maintains a detailed audit trail that records every action, edit, approval, and timestamp throughout the process, ensuring full transparency and compliance with FDA 21 CFR Part 820, ISO 13485, and other regulatory standards. 

9. Can a medical device QMS handle both design controls and post-market surveillance?

Yes, Kivo QMS handles the entire product lifecycle, from initial design controls through post-market surveillance activities. This includes capturing user needs, design inputs, verification/validation records, and ongoing data from complaints, adverse events, and field actions. Having all phases connected within a single QMS helps ensure traceability, accelerates audits, and supports continuous product improvement after market launch.

10. How long does it take to implement a QMS for a medical device company?

While most QMS providers promise timely implementation, the most popular legacy systems usually take 3-6 months to rollout, and that doesn't even include the lengthy training needed to get teams up to speed. By contrast, Kivo offers a modern, pre-validated QMS platform that can be deployed in just a few weeks. Our solution is 1/10th the cost, incredibly easy for your entire team to learn, designed specifically for medical devices and combination products, and able to be fully operational within the next few weeks. Enter your info below to see Kivo QMS in action and learn why so many life sciences teams are switching to our system.