Medical devices facilitate affordable and quality patient care as these are useful in preventing, diagnosing, and effectively treating medical illnesses. Medical devices are also useful in monitoring treatments and aiding disabled populations to enhance safety. Thus, they are fundamental and integral components of healthcare systems.
Due to advancements in technology and pathbreaking progress in the innovation of medical equipment, it is now possible to detect and diagnose, prevent, and provide for accurate treatment of illnesses, thus saving the lives of many people. The proven advantages of medical devices have paved the path to an increase in their adoption amongst the population at large.
The global medical devices market is projected to grow from $495.46 billion in 2022 to $718.92 billion by 2029 at a CAGR of 5.5%. (Fortune Business Insights)
However, before any medical device is introduced to the market or the inclusion of new features to the device, it needs to go through a verification and validation process. Medical devices must be compliant with regulatory standards followed across the globe (or meet the minimum standards in the geographical area of usage) before they are used on/by patients. The validation of medical devices is to ensure there are no deficiencies, or errors and the device meets the quality that matches user needs for its intended use.
The healthcare industry is evolving and, in its attempt to keep up with the latest technologies, it faces many challenges. The challenges have no ready solutions when it comes to meeting regulatory standards. The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities and the numerous regulatory bodies (FDA, EU MDR, EU IVDR) that it must pass through before being accepted.
The regulatory changes in healthcare and life sciences sectors affect diagnostics, medical devices, and pharmaceutical organizations. These regulatory changes are introduced to ensure patient safety and product efficiency throughout the product lifecycle. Device manufacturers would certainly not like any hindrance in delivering malfunctioning or bad quality medical devices. And thus, they need to avoid any issues with respect to compliance with a medical device. Medical device companies need to proactively prepare for changes as these can affect their current and future business substantially.
For medical device manufacturing, compliance remediation is a process of recognizing problems in advance that may arise during the product lifecycle stages. To mitigate any issues that can affect production and meet compliances, the manufacturer needs to chalk out a plan to resolve, correct, and prevent those problems that can affect them from occurring in the future.
The regulatory agencies are tightening the regulations on medical device companies around standards and compliance standards. So medical device companies prefer to go for effective remediation processes that identify the root cause of problems and have a comprehensive plan to remedy them and communicate those changes to regulatory authorities conclusively.
Documentation of process evidence is key to regulatory compliance. Companies need to maintain documentation related to the finished medical device to show that the design controls process was followed in accordance with the standards and documented throughout the product development. A lack of proper process evidence at the time of unannounced inspections result in failed audits and recalls can occur. To prepare for unexpected inspections, manufacturers need to ensure that their process evidence is audit ready. A well-organized Design History File (DHF) ensures a smooth audit preventing delays, costly reworks, and recalls in the future. The completeness, and accuracy of DHF provides a smooth audit process.
DHF (Design History Files)
Design History Files (DHFs) are a collection of documents that describe the design history of a finalized product. It should include design review, verification, and validation of devices. This is required by the FDA (Food and Drug Administration) as part of the design controls (21 CFR Part 820.30).
A detailed design control process ensures that the DHF contains all the verification records required by the regulatory agencies meeting all the compliances of various geographical regions. As the medical device regulatory requirements change, the quality systems need to be updated as well thus ensuring the verification records in the DHF are compliant with the new standards. This process of ensuring that the verification records for medical devices are compliant with the new standards is termed as verification in remediation. For legacy medical devices, ensuring that Design History Files (DHFs) of existing products are compliant with the new regulations is very critical to ensure its continued usage.
DHF remediation is the review of the Design History Files of legacy products that are already present in the market. It is crucial to ensure its compliance with regulatory standards. Legacy medical devices lack the required documentation to meet the present compliances and regulations. Here is when the remediation approach of DHFs can be employed. This can be achieved by using the existing documents and identifying the gaps in the design control elements.
Medical device companies need to introduce newer and better features to stay one step ahead of their competitors. Medical devices along with key USPs of a product are modified using the existing product with new features, to add value and upgrade the existing version. With the addition of new features, the DHF needs to be updated to meet compliance standards. Also, when the regulatory requirements change, once the quality system is updated, it should be ensured that the DHF of the legacy products complies with the new standards.
Benefits of Remediation:
- Ensures patient safety by minimizing the risk of device-related injuries and adverse events
- Follows tracing protocols to facilitate recalls in the case of serious risks to health presented by the devices
- Management reviews: These are post-marketing strategies to understand whether management efforts are aligned with product performance against quality, manufacturing issues, and complaints
- Corrective action planning
A remediation plan needs to:
- Identify non-compliance and assess its impact on the product and organization
- Recommend corrective revisions and preventive actions
- Address safety and performance concerns
- Assist in remediation paperwork, regulatory compliance documentation, and submissions
Remediation is a set of time-consuming and complex tasks, and one needs accurate know-how of the remediation processes. For the remediation process to be successful, a well-designed strategy, robust documentation, and an efficient end-to-end delivery is essential.
The proper strategy to update DHF at the beginning of the product life cycle wins half the battle towards its success. A strategy includes assessments of the risks of the device, knowing appropriate issues to be resolved based on the risk assessment, making sure to complete required documentation, and document data that proves the device is safe for use and functions effectively. Medical device companies are thus building a robust compliance program to detect, prevent, and remedy any non-compliances to avoid costly remediation.
Bringing a medical device to market that is trustworthy and meets end users’ increasing demands and industry standards needs a proper regulatory strategy. Companies can reduce time to market when the processes are streamlined properly, and each cycle is documented as per the regulations and DHFs.
A medical device company, nonetheless, needs to work with a partner company who can employ their strategies and expertise to remedy the lapses that arise due to non-compliance. An ideal vendor also ensures the prevention of such non-compliance in the future.
As a part of the remediation project, Decos with their team of experts applies industry-defined standards in software design and maintains an effective compliance program to minimize costs. We work with medical device equipment companies to help meet their goals by abiding to all regulatory norms.
This article was provided to you by Decos, a cutting-edge technology services partner ready to meet your software needs in the medical domain. If you have a question on one of our projects or would like advice on your project or a POC, just contact Devesh at email@example.com. We’d love to get in touch with you!