Quality Management Challenges for Medical Device Industry
Medical device is backbone of the healthcare industry. The correctness and accuracy of these devices greatly affect the quality of treatment a patient receives. Be it Class I, Class II or Class III medical device, quality of every device is important.
In other words, quality of a syringe or a bandage is equally important as quality of a ventilator or a pacemaker. All categories of medical devices play a crucial role in providing apt healthcare facility to the patient.
Amidst the responsibility of producing accurate results, the manufacturers of such devices bear responsibility of navigating swiftly through tides of FDA, ISO, and other regulatory requirements.
Moreover, the medical devices must be accompanied with booklets and user manual which is easy to understand and follow for common man to use. So, explaining the complex medical terms/devices in simple layman language is yet another challenge these manufacturers face among many others.
Here we will discuss various quality management challenges that medical device manufacturers face and try to give a probable solution as well.
So, what are the challenges?
As discussed earlier, there are many challenges medical device manufacturers face. Some of these are as below:
Be always audit ready — FDA never warns before audit. The authorities barge in without any notice. Therefore, organizations must be always audit ready. They must have processes, quality documents, trainings, government approvals ready at all the time. Along with this, they need it to produce it to the authority at the right time.
Most of the organizations have discrete systems for these documents. Taking out information from these siloed systems is a time-consuming task. Due to lack of visibility into various siloed systems, data fetching and collaborating yields erroneous results, increasing chaos at auditee’s end. Moreover, at the time of audits, the stress level increases, valuable time is wasted, and people are involved in non-productive tasks.
Solution to this challenge is a digital QMS software which can centrally store all the data and provide access to it from anywhere, at any time.
BM QualityMaster is one such solution. It is a robust QMS software with document management module. Amazing features of this module include:
- It tracks all documents activities and maintains audit trail of who viewed the document, when it was accessed, and who modified it.
- Indexes and searches documents via metatags/metadata with different search terms.
- It provides document access controls via passwords to ensure role-based access.
- It sets up alerts and notifications for release, expiry, review, update, or approval of documents.
Along with document management, it can be associated with training module, tracing and tracking requirements of training.
Get closed loop of CAPA –
For medical device manufacturers establishing CAPA is essential. CAPA stands for Corrective and Preventive Actions. It involves from identifying the issue, to its analysis and final solution.
For many systems, identifying the issue is a pretty simple job but identifying the root cause is a complex job. It is a complex one especially when QMS and CAPA are not connected to product records. This isolation makes it difficult to zero in on the part of product or manufacturing process that is responsible for quality issue.
In many instances, medical device manufacturers maintain QMS and CAPA processes that either operate in isolation or have only loose connections to the product record. Consequently, this situation worsens the difficulty.
To effectively close the loop, it becomes imperative to implement the necessary corrective and preventive actions aimed at rectifying future quality issues. The efficient closure can be achieved only when quality and product information are interconnected and facilitate seamless determination of root cause during analysis.
Solution is a product centric QMS for medical devices solution, just like BM QualityMaster.
Its comprehensive CAPA module helps you to:
- Establish a regulatory-compliant Corrective and Preventive Action (CAPA) workflow procedure, complete with defined action routes.
- Streamline and automate CAPA implementation by digitizing CAPA related documents, forms, and approvals.
- Trace potential quality issue from start to end with uniform dissemination of facts.
- Connect easily with other modules like SOP, Audit Management, Change Management, Training Management etc for speedier actions.
- Identify the areas to be impacted or affected with CAPA and pre-inform the concerned departments for faster actions.
- Send alerts to all impacted departments and achieve continuous improvement by refining processes, enhancing training, strengthening quality control measures, etc.
Instil continuous improvement- Lack of single, and cohesive system to address quality management and the product record is a challenge many medical devices manufacturers face. In such systems regulatory compliance becomes challenging as teams struggle to identify and track records.
Solution is a transparent quality culture which can be instilled with an electronic medical device quality management system, like BM QualityMaster.
Swiftly identifying and rectifying problems within a transparent system grants a competitive edge, expedites adherence to regulatory requirements, and accelerates product market entry. Additionally, these help medical device manufacturers in creating products that not only are safe to use but show enhanced reliability.
Conclusion
The medical device industry faces multidimensional challenges in ensuring product quality and regulatory compliance. Navigating this complex landscape demands innovative solutions and a commitment to excellence.
As we’ve explored, the implementation of digital Quality Management Systems, such as BM QualityMaster, holds the key to streamlining processes, enhancing collaboration, and ultimately delivering safer and more reliable medical devices. These systems provide the foundation for staying audit-ready at all times, achieving a closed-loop CAPA process, and fostering a transparent quality culture.
When medical device manufacturers embrace these transformative technologies and approaches, they can thrive for innovation, and ensure patient’s safety.
If you are a medical device manufacturer looking forward to inducing a quality culture in your organization, please feel free to Get in touch with BM QualityMaster.
