Understanding the Implementation of a MedTech QMS: the What, Why, When, and How?

Introduction

This write-up provides insights into why medical device companies must have a Quality Management System (QMS). It also offers guidance on when a company should consider implementing a QMS, and practical approaches that can be utilized in pursuit of this goal. This blog is specifically aimed at helping medical device startups gain insights into what a QMS is, why it is needed when it should be implemented, and the approach to doing so.

Background 

Bringing any innovation and technology to the market poses numerous challenges. For medical devices, these challenges are amplified. Additional barriers arise from the stringent regulations governing the medical device industry, which vary depending on the technology being developed.

In the United States (US), the FDA’s medical device regulations are outlined in 21 CFR 820[1], known as the Quality Systems Regulations. Similarly, in the European Union (EU), the Medical Device Regulation[2] (MDR) describes these regulations.

Both the US and EU regulations not only stipulate the requirements for establishing sufficient data to ensure device safety and effectiveness but also dictate how medical device manufacturers must operate across their organizations. This encompasses all aspects related to product development, manufacturing, supply chain management, commercial distribution, post-market surveillance etc.

To maintain compliance with these regulations, medical device manufacturers must establish a Quality Management System (QMS). A QMS comprises policies, processes, and procedures governing the organization’s operations to ensure adherence to regulatory standards.

Decades ago, the norm was to operate within a “paper-based system,” wherein all policies, procedures, and documentation related to product design were maintained in physical paper copies, typically stored in fireproof cabinets. Today, the standard practice is to use software to manage a QMS, often referred to as an electronic Quality Management System (eQMS). This software automates certain regulated processes of the QMS and serves as a document repository, thereby enhancing efficiency and facilitating compliance for medical device organizations.

Foundational Pillars: Building a Robust and Compliant Quality Management System

The Quality Management System itself is composed of various policies, Standard Operating Procedures (SOPs), templates, work instructions, and forms. These documents, typically in formats such as Microsoft Word, describe how an organization operates to maintain compliance with regulations and form the foundation, or first “pillar,” of a QMS.

A document set like this, often referred to as a QMS documentation package, can be obtained as templates from third-party consultants. While these templates are often based on industry best practices, it’s crucial that the documents are updated to reflect the organization’s device technology and business processes. Many startups make the mistake of acquiring a QMS documentation package, without updating it to fit their business, thus ending up operating out of compliance which can lead to documentation gaps and audit findings. 

The second pillar of the QMS is typically an eQMS software that automates certain processes of the QMS. One example is QuickVault[3], provided by Veeva Systems, Inc., which serves as a repository for QMS documents and related information. With an eQMS, document approvals are done electronically, complying with FDA regulations outlined in 21 CFR Part 11, and providing revision control and traceability.

In addition to document control and document change control, eQMS systems such as QuickVault offer functionality for training, managing quality events, Design Controls[4], risk management, supplier management etc. For first-time founders in MedTech startups, this functionality can be tremendously helpful as it simplifies the processes needed for compliance thus resulting in reducing the time to technology commercialization. 

The third pillar of a QMS is the knowledge of the employees within the organization. Employees must have appropriate knowledge and experience, and be formally trained in various aspects of the QMS depending on their role. In addition to receiving the necessary training, first-time founders should consider contracting a third-party consultant as a part-time Quality Assurance (QA) lead is advisable to provide training and support to the team. A QA lead can also ensure the QMS remains up-to-date, and that documents related to device development, manufacturing, product distribution etc. are created and maintained in accordance with regulations.

Timing QMS Implementation: Navigating the Transition from Research to Development 

A medical device company is typically founded based on the identification of a need of some sort. The need can be challenges during a surgical procedure, issues that patients face in their homes or other situations. In the case of medical devices, these needs are around the diagnosis or treatment of medical conditions, and the solution to address these pains is typically through a technological innovation – the medical device. Early in the journey of a medical device startup, the focus is thus on technology development and validation that the technology will properly eliminate or reduce the identified need, and that someone is willing to pay for the device. 

In technology development, the term R&D is often used. This is an acronym for Research & Development. Early medical device development is often referred to as the “feasibility stage” where prototypes are created and evaluated to assess whether an idea will actually solve the identified need or not. The feasibility stage is basically the research part of R&D, the “R”. This effort is typically defined by rapid iterations of technology and associated prototypes, various types of testing and evaluations of these prototypes, to find a design that properly addresses and solves the identified problem. This approach is similar whether the device is a hardware device (for instance a surgical tool) or a software device (such as a mobile app for skin condition diagnosis). 

After the build and testing of multiple iterations and prototypes, the research phase will eventually come to an end when a reliable design has been developed. The design should provide a high level of confidence that the innovation will be solving the identified problem or need, and that the device can be manufactured and sold with a profit. This point of technology development is sometimes referred to as “design selection” or “design freeze”. Following design selection, the effort will move into the formal development of the device, the “D” of R&D. Figure 1 below provides a visual of the journey from Research into Development, and where design selection takes place. 

Figure 1: The R&D journey and the point for design selection 

At the point of design selection, a QMS shall be in place, as the development of a medical device is subject to the FDA’s Design Control Regulations[4] (21 CFR 829.30) and the design and development parts of ISO 13485[5]. Thus, once a technology is past the research stage and is entered into formal development, regulations apply for how the development of the finished medical devices should be conducted and documented. In addition to being in compliance, developing the device according to the regulations is crucial as the data that is gathered to demonstrate device safety and effectiveness is expected to be presented to regulatory authorities in a specific manner, for instance within a marketing submission such as an FDA 510(k). 

For a MedTech startup to not have any delay in development, or possibly end up in a risk of continuing device development out of regulatory compliance, a QMS shall be implemented ahead of design selection. As a guidance, once the research stage of a technology is within 3-6 months of arriving at design selection, a QMS shall be established. 

Documenting the Research and Development Journey: From Concept to Finished Device

During the research or feasibility phase, there is no regulatory requirement for documenting prototypes and associated testing. However, industry best practices dictate that this work should be documented in lab notebooks, feasibility reports, etc. If a QMS is available, it’s advisable to create and approve feasibility reports within the system, as they serve as important references in the documentation for formal device development, such as the Development Plan.

Regulations also do not specify when design control regulations apply. Some companies opt to apply design controls during the feasibility stage, while others do so at the point of “design selection,” when the intended design for market release has been established. Typically, it is advised to apply design controls at the point of design election and not in the feasibility stage, as the documentation requirements and requirements around revision control can slow down the speed of rapid prototype iterations.  

In documenting the development stage of medical device technology, adherence to design control regulations is imperative, as mentioned earlier. Following these controls generates the necessary documentation for regulatory compliance and marketing submissions, such as an FDA 510(k). The output of design controls includes evidence of device safety and effectiveness for its intended use, which constitutes part of the Design History File (or Technical File in the EU). Failure to follow a QMS and associated design control processes may result in inadequate documentation for a successful marketing application, potentially requiring redoing various studies to demonstrate device safety and effectiveness. Thus, having a QMS and the knowledge to follow design controls is crucial when embarking on the formal development of a medical device.

Strategic QMS Implementation: A Two-Stage Strategy

As most medical device startups have very limited resources (people, time, and money), it is usually advised to implement a QMS in two stages: a pre-commercial stage and a post-commercial stage. By dividing the QMS into these two segments, the team can initially focus on establishing the necessary components of the QMS, particularly those related to device development, to progress the company toward regulatory submission. As the company approaches its marketing submission timeline (around 3-6 months prior), consideration should be given to implementing the second stage of the QMS.

The second stage encompasses SOPs and processes concerning product distribution, as well as procedures for handling field events such as customer complaints. At this juncture, it is also advisable to appoint a full-time Head of Quality Assurance, either as an employee or a contracted third party.

Initiating the Implementation of a QMS: First Steps Forward

Hopefully, this blog has shed some light on the necessity of a Quality Management System (QMS) and provided insights into when and how to implement one. If you’re at a stage where it’s time to consider QMS implementation, here are a few steps you can take:

• Initiate discussions with third-party consultants who can assist with implementation and provide tailored templates for your business.
• Explore electronic QMS (eQMS) solutions like QuickVault. Veeva offers a blog on due diligence for eQMS systems and their providers, which you can find HERE.
• Reach out to the QuickVault team for further assistance and to discover how QuickVault can support your business in both pre-commercial and post-commercial stages. As part of the QuickVault subscription, customers receive a complete QMS template package valued at $10,000.

References 

1. FDA Quality System Regulations for Medical Devices, 21 CFR 820: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 
2. The Medical Device Regulations (MDR): https://eumdr.com/ 
3. eQMS software, QuickVault: https://quickvault.veeva.com/
4. FDA Design Controls, 21 CFR 820.30 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.30 
5. ISO 13485 – Medical devices, Quality management systems, Requirements for regulatory purposes: https://www.iso.org/iso-13485-medical-devices.html