Choosing a QMS for Your Medical Device Company? Here’s What to Look For

The medical device industry is strictly regulated, given the implications of its products on users' health and safety. Since medical devices are used for therapy and treatment, the outcomes must be as expected with minimum deviations or breakdowns. Any performance, quality, or safety issues can impact patient health, brand reputation, and regulatory compliance - all of which will have a direct impact on the company’s financial performance.

Therefore, an efficient and effective quality management system (QMS) becomes critical for such companies. Regulatory standards also require medical device manufacturers to implement a risk-based and automated quality management system.

Using a modern, cloud-based QMS solution that can be configured for specific requirements of the medical device industry, therefore, will be a game changer. It’ll certainly play a role in improving the overall quality performance and efficiency of the end product.

Why Cloud-Based QMS for Medical Device Manufacturing?

To ensure the success of the product in the market, a medical device manufacturer must ensure the following aspects are taken care of:

• The quality and performance of the product must be in line with the original expectations.
• The medical device must comply with all applicable regulations and standards, including those specific to the local geographies they operate in.
• It is important to have end-to-end visibility into all processes, including those of external stakeholders such as suppliers, distributors, manufacturing partners, etc.
• Leaders must ensure that compliance documents are easily accessible and are modified with proper version control/change management procedures.
• Training and development of all key personnel across the value chain will play a key role in ensuring continuous improvement.
• All employees/contractors must have easy access to SOPs and other documentation needed to perform their tasks.
• Periodic audits and inspections to detect any noncompliance or potential risks.
• Risk assessment and risk management are vital factors to plan for.
• Performance and maintenance of all assets/equipment/machinery across all locations.
• Conformance of products and processes to specifications and standard operating procedures.

The list is long and the demands on resources, are high. A manual system cannot provide a unified view of data/information to identify potential issues. Regulations also require the medical device manufacturer to implement a culture of quality, where every employee takes ownership of their tasks and ensures alignment with quality standards. With regulations and markets constantly changing, employees can find this challenging and may ignore quality in a bid to shorten time-to-market.

Therefore, medical device manufacturers need a cloud-based quality management system that can help automate processes, provide a unified view of data, improve efficiency, visibility, and transparency, and empower workers with tools to proactively identify risks and opportunities for continuous improvement of the QMS.

However, many solutions are available on the market, and identifying the right EQMS Solution can be challenging.

5 Things to Look for in a QMS for Medical Device Manufacturers

A device manufacturer must look for the following 5 aspects in the QMS before deciding on it.

Factor #1: Regulatory Compliance

Being compliant with regulatory requirements is a must. But, it is not just for this reason that a medical device manufacturer needs to be compliant. The regulations are a work in progress that constantly evolve to make the related businesses provide quality and safe products to customers. Therefore, beyond compliance, businesses must look to establish a proactive culture of quality. This helps incorporate a risk-based approach to quality management and improves compliance, brand reputation, and customer loyalty.

Factor #2: Ease of Regulatory Submissions

Regulators need documents to be submitted regarding different aspects of the manufacturing process, quality-related events, etc. as proof of compliance. Creating the document, and ensuring timely approvals from relevant stakeholders, submissions to relevant regulatory authorities, etc. can be cumbersome and a drain on resources. A cloud-based QMS solution with an integrated document management system can automate the process, thereby reducing the demands on resources and allowing them to focus on their core business. It should also allow electronic submissions to the regulatory authorities with ease as that is what is the preferred mode.

Factor #3: End-to-End Integration of Processes

Quality touches all aspects of a business. Right from managing the product lifecycle to post-market surveillance, customer feedback, and regulatory compliance, quality has a critical role to play in each of these processes. While each of the processes may run on a different system - ERP, SCM, PLM, CRM, and so on – a unified platform is a must for obtaining a single source of information for greater visibility and transparency. A cloud-based quality management system must act as that platform, thereby ensuring quality processes are standardized and business leaders get a unified view for taking timely action driven by informed decisions. This helps unify technology, people, and processes and respond to issues in real time.

Factor #4: Customization and Scalability

A business is constantly growing, and with that growth comes the need to fine-tune processes, scale up, and also connect and add remote locations. The software one invests in must be scalable, flexible, and configurable to meet the ever-changing requirements. It must also have a robust change management system to help business leaders assess the impact of the change, monitor its progress, and then implement it company-wide, correcting courses where needed. This will improve the impact of the changes and ensure that the desired outcomes are met smoothly.

This is applicable in case of regulatory changes too, allowing businesses to assess the impact of changes on processes to meet the new requirements and monitoring and tracking to ensure its performance.

Factor #5: Dashboards and Analytics

AI-powered reporting and analytics are critical in today’s fast-paced world to augment human decision-making by providing recommendations based on historical and current data. The insights can improve human decision making by providing the pros and cons of a particular course of action and providing a cost-benefit analysis. This can also empower businesses with information on current, future, and potential risks to capture trends and prepare them better for the future.

Prepare Before Choosing the QMS

Before finally making the decision based on the above criteria, prepare your business for the transformation to a new system.

• Conduct a Gap Analysis: Know your strengths and weaknesses and identify areas to focus on first. While many quality management systems may offer a range of features, investing in all of them in one go may be difficult, costly, and unnecessary. Therefore, choose what needs to change right now and start from there.
• Shortlist the Right Fit: Identifying critical needs will help you zone in on the QMS that best meets your needs and can help you reap the benefits quickly. Compare and contrast features of different quality management systems, check how aligned they are with the relevant regulations, and determine whether they are scalable.
• Request a Demo: A demo will help you understand whether the product delivers what it promises and how easy it is to integrate with your current systems. It must have an intuitive interface that is easy even for the last man on the shop floor to use. Scalability is another feature to test for.
• Conduct a Cost-Benefit Analysis: Cost includes many things and not just the price of the software. There could be charges for installation, training, and maintenance. Everything together constitutes the total cost of ownership, which must be calculated to ensure it fits the pocket.
• Support: While the software may be intuitive and easy to use, what is the reputation of the vendor in the market? Will they be able to provide sustained support? How committed are they to the product and you, the customer?

To know more about ComplianceQuest QMS and how it fits your needs, visit https://www.compliancequest.com/quality/