Quality Best Practices For Medical Device Manufacturing
Medical device manufacturing is a complex domain, where precision has to be a priority at all times. As a manufacturer, ensuring quality is not just a business requirement. It is also an ethical responsibility. After all, the smallest flaw or defect can cause grave danger to patients. Therefore, embracing quality best practices is not a choice for medical device manufacturers. You have to do it to ensure top-notch products that are safe and compliant with the regulatory norms.
Implementing quality best practices ensures that the manufacturing process is consistent, efficient, and complies with established standards. This helps prevent defects and errors in the manufacturing process, which can lead to costly recalls and damage the manufacturer’s reputation. Here is the checklist of best practices you must follow at all times.
1. Create a viable quality plan
A viable quality plan is the mainstay of successful manufacturing, regardless of the product you create. It establishes expectations and metrics that enable you to measure quality. Further, it outlines your policies, procedures, and guidelines. A plan helps you to verify that your process meets quality requirements. You may have to tweak it down the line as regulations change or better things come around. Make sure it is flexible enough to accommodate such changes.
The plan should have an inspection and testing section that describes the procedures for inspecting and testing the product or service, including the types of tests that’ll be performed and the acceptance criteria that must be met.
There should also be a section for training to detail the training that will be provided to employees to ensure they understand and follow established quality procedures. Lastly, the plan should have documentation to record all aspects of the quality plan, including materials, processes, equipment, and inspection tracking.
2. Monitor design control
Design is perhaps the most crucial element of quality management for the medical device manufacturing industry. Ensure that you implement design controls that cover the patient’s needs with both the science and engineering aspects. Simply speaking, they should deliver comfort and safety for the patients and precision and convenience for the practitioners. Manufacturers should track customer feedback or complaints of the existing products and take relevant steps to improve them accordingly.
In addition, while creating the device, there should be traceability, so you’ll know at what stage the product met some obstacles and victories. This also helps investigate recall incidents, and determining liability will be more straightforward; this can especially be helpful in a device with many components from different manufacturers.
3. Think beyond design
Design is the mainstay of medical device manufacturing, but much more goes into product quality. Choosing the right coating material, for example, can go a long way in determining the usability, safety, and longevity of products.
Such is the reliability of Korvus Technology‘s highly modular PVD system. Their highly modular PVD (Physical Vapor Deposition) systems are advanced manufacturing systems that allow for the precise application of thin film coatings on a wide range of materials.
These systems are composed of several individual modules that can be configured in various ways to achieve specific coating properties. Quality managers need to dig deeper into industrial applications for coatings to pick the apt material for medical devices. The objective should be to improve continuously and switch to better options when available.
4. Use audits as a valuable feedback
Medical device audits are a part of the quality management process as the FDA necessitates them for the industry. But think beyond regulatory compliance as you conduct internal audits for your business. Consider them as a valuable source of feedback you can use to improve your products down the line. Implement better quality assurance procedures to pick the smallest concerns during audits and improve on them to create flawless end products.
5. Establish a stringent documentation process
Quality management in medical device manufacturing requires robust documentation. It enables you to maintain detailed records of defects and corrective actions for future reference. Further, documentation is essential from the compliance perspective. You must maintain records throughout the design, development, licensing your medical device, and manufacturing operations. Additionally, keep track of supplier evaluation records, approved supplier lists, device history records, non-conformances, complaints, and customer feedback.
Medical device manufacturers need to ensure quality for every product they create. The task sounds daunting, but implementing these best practices can keep you a step ahead of expectations and regulations. Embrace them as a part of the medical device manufacturing process, and you will never have to worry about defects and non-conformances again.