Regulatory compliance, product safety, and product efficacy are just a few of the unique quality management difficulties that MedTech and biotech companies face daily. However, by solidifying a QMS (quality management system) in place, your business can tackle these difficulties while maintaining the highest levels of quality in both your products and services.

You might be asking yourself, "What is a quality management system?"  

QMS’ are production-related policies and processes or record-keeping tools that are put in place before or during production to help you address and avoid issues with your product. If you are manufacturing products subject to FDA regulation, every stage of the design and production processes must be recorded in order to provide proof the required elements were performed. Without documentation or with improper documentation, you may incur additional costs, FDA citations, or repetitive work, all of which result in lost time.

In general, having a strong quality management system indicates strong regulatory compliance. In this learning resource, we will discuss why it is vital to establish a QMS, when implementation would be appropriate for your biotech or MedTech company, and how to put a solid quality management system in place.

Table of Contents:

• Why you should implement a QMS NOW!  
• When should your QMS be integrated?
• How to put your QMS into practice.
  

Why you should implement a QMS, NOW!

The quality management system is the foundation for all systems and processes and is a critical prerequisite for all regulated sectors in MedTech and biotech to offer an FDA-approved product. It provides assurance that procedures are in place to guarantee a well-run, compliance study or product with results that can be independently validated. Let's delve into the seven main reasons why establishing a QMS is necessary.

1. Compliance: MedTech and Biotech companies are subject to various FDA regulations, Good Manufacturing Practices (GMPs), as well as ISO or other international bodies. By putting a QMS in place, your businesses can assure a smooth transition into regulated environments, maintain compliance, and avoid hefty fees and penalties.

2. Patient outcomes: MedTech and biotech businesses provide solutions that directly help treat patients. A critical step in preventing patient complications and enhancing patient outcomes is the implementation of a QMS. You can then ensure that your products are safe and effective for use.

3. Consistent product quality: Considering the possible life-saving potential of the items produced, quality is crucial for life science companies. By putting a QMS in place, you can ensure that your business consistently produces high-quality goods that always match or exceed client expectations.

4. Enhanced productivity: A QMS can help your business' operations run more smoothly by minimizing waste, rework, and errors. This can help you save time and money while also increasing productivity.

5. Constant improvement: A quality management system fosters a culture of continual improvement. In doing so, you can be sure that your business is constantly looking for ways to enhance its operations, products, and services. As a result, this can lead to improved innovation, competition, and, ultimately, market share.

6. Audit Readiness: During an inspection, auditors look for evidence that you are following best practices and adhering to your QMS; this generally takes the form of verifying documents or other production records. Therefore, having a robust QMS in place will help you in streamlining your product or service.

7. Maintaining Competitiveness: Having a solid quality management system will help you stay one step ahead of your competitors, resulting in fewer financial and consumer losses.

When should your QMS be integrated?

While creating a QMS as soon as possible in your MedTech or Biotech organization is ideal, it is never too late to implement one if you haven't already. Some companies have overlooked this step of adopting a QMS, but as regulatory submissions begin, you may discover why having one was vital in the first place.  

Although most regulatory submissions today require the manufacturer to have a QMS in place before a product is placed on the market, let's dig deeper to see when the optimal time to deploy a quality management system would be.

1. Launch a quality management system as soon as possible! Ideally early in the product's life cycle, during the design phase. It is easier to be certain that your product is designed in line with the numerous regulations when processes and procedures are in place. Additionally, it offers a higher chance of success when making a regulatory submission.

2. In the US it's illegal to put a device on the market without registration and listing. To register an establishment with FDA, the establishment must have a QMS. Internationally, the body will not audit you for market entry without the demonstration of a QMS in place.

3. When your product is entering new markets, it is important to address the various standards that must be met because a different region or market may have different legislation and quality requirements. For instance, many international organizations demand that their suppliers be ISO 13485 certified to demonstrate that their product is internationally recognized as safe.

4. It is critical to build a QMS before encountering any quality concerns or recalls in order to identify and address the main cause and prevent future occurrences.

5. QMS development can be costly, but there are various software programs tailored to your business that can be adopted, whether you're a large, well-established company or a small start-up. Even a partial quality system that is lean and scalable in its early stages, like the use of Design Controls, might be advantageous to startups.

6. An early-stage QMS is appropriate for medical device manufacturers who are between 18 and 24 months from commercialization and distribution, meaning when regulatory submissions are close to being filed, and when clinical trials are going to start. 
7. If your company is gradually growing its workforce, has several products launching soon, has won several bids, or is experiencing additional growth, it is time to invest in a quality management system.

How to put your QMS into practice.

It is critical to highlight that the implementation of a QMS should be adapted to the demands and objectives of your unique company. You can always leverage a team of professionals, consultants, or CROs like Proxima to collaborate with and ensure that your QMS is effective, successful, and the proper match for you. Let's explore how you can bring your quality management system to life.

1. Understand your industry and product: QMS systems for MedTech and biotech companies differ from one another. For example, if you are a medical device manufacturer, depending on the complexity of your device, such as Band-Aids (Class I), Syringes (Class II), or pacemakers (Class III), you will have different requirements for your QMS. Prior to implementing a QMS, it's important to know your product, industry, and audience.  

2. Create a quality policy with goals in mind. Start from the beginning and create a clear policy that is consistent with your company's vision and values. This also means developing quantifiable, achievable goals that are in line with your entire business plan. Consider using this time to lay out your timeline and all the required certifications.

3. Clearly identify requirements: Determine which laws, regulations, policies, and quality standards, such as FDA regulations, Good Manufacturing Practices, ISO standards, or country-specific legislation may apply to your products and services. Create a strategy to address these demands.

4. Create policies and procedures: Establish policies and procedures that cover all facets of the QMS, such as design and development, production, and distribution. For reliability and traceability, it is important to document the results of these procedures.

5. Prepare your team for the QMS implementation: Quality management system training and deployment are critical to ongoing progress and improvement. By routinely evaluating employee competency and offering extra training, you can make sure that staff members are aware of their duties and responsibilities.

6. Create a system to assess the efficiency of your QMS: Using document maps or organizational charts, create metrics and key performance indicators (KPIs) to control and measure the quality of your QMS. This is also the time to create procedures for data collection and analysis, to then use the results to pinpoint areas that could use any improvement.

7. Constantly evaluate and enhance the QMS: In order to determine whether QMS requirements are being met, this step comprises routine internal audits and management reviews. Internal or external SMEs (subject matter experts) may be brought in to assess the QMS, detect strengths, spot areas for development, and suggest adjustments as necessary. For example, an SME may suggest you enhance your QMS by obtaining certifications to show commitment to quality.  

Early implementation of a quality management system can save your biotech or MedTech company from additional expenses and lost time in the long run. Making your QMS an integral part of your company’s operations will have a direct impact on the quality, certainty, and approval of bringing your product to market.

It is critical that your products meet regulatory requirements and safety standards, and a QMS can help you in doing so while also enhancing overall efficiency and encouraging continual improvement. Ultimately, to thrive in any industry, you must have customer satisfaction, and the end goal of a quality management system is to demonstrate that products and services are generated and delivered to patients in a predictable and safe manner.