7 Common Medical Device Regulatory Compliance Problems
From hearing aids to ultra-tech pacemakers, the medical device industry is a ground-breaking and innovative field full of opportunities. Though the manufacturers are passionate about delivering high-quality and safe products to market, uncertainty lies ahead. The new emerging regulatory compliance services, complex reimbursement rules are engraving the companies to face a cutting-edge competitive scenario. These challenges have called the medical device industries to produce cost-effective products, streamline the operations in line with regulatory compliance and bring in innovative devices more quickly.
With the emerging technologies, medical devices are a cost factor despite their long-term cost-saving modes and improved patient safety measures. However, medical device manufacturing companies should take precautions to avoid compliance regulations issues.
Let’s look at the most common medical device regulatory compliance problems faced by quality leaders in the 21st century.
Ensuring Consistency in Quality
The ultimate motto of a quality leader is to avoid product recalls as it hinders organization and brand reputation. The medical device industry should consistently produce high-quality products, thus ensuring the delivered products are safe, secure, and reliable to use.
Developing a medical device right from a Syringe to Robot Surgical Machine, the manufacturers should comply with the FDA (Food and Drug Administration) medical device regulations and other regulatory standards that differ with the country.
Innovative Software-Driven Medical Device
Technology innovations have spread their wings, dominating the core features and functionalities of medical devices, increasing development works in producing the innovative medical equipment types. Good that the aid of the regulatory standard in the more straightforward development process and administrative tasks but impact the medical device system’s legal credibility and certainty.
With constant evolving technological advancements, manufacturers should grab this opportunity to streamline device design and development processes and stay ahead of the innovative competition. Additionally, to overcome the device regulatory and compliance credibility, implementing the data management strategies that provide data transparency will help.
Document Management
Document management is a process of managing and securing documents from the initial discussions of device development till its inception. It plays a vital role in life science industries and is one of the base pillars of medical device manufacturing companies. The documents and process records prove the company’s adherence to FDA and ISO compliances/regulations. So, here, documentation not only refers to the design and development process of a device and includes SOPs, Process Manuals, and other items documented by the life science industry as laid by the regulatory standards.
ISO 9001 FDA Medical Device Regulations
ISO 9001/ FDA medical device regulations limit the document management strategies or control the format, label, and approvals. If the quality leaders failed to maintain the docs, then their products are of no value. Hence, it’s essential to maintain and store the docs securely with precise and updated information for the auditors to find the most relevant and up-to-date versions. Additionally, the statement that is documented is authorized with designated signatories and is secured from misuse.
Rather than paper documentation, automation and digital data transformation solutions would be impactful in device regulation inspections as the audit logs are available at any point in time with ease. Streamline processes and procedures for the employees to follow easily make day-to-day tasks, handovers, and training much more effortless. Establishes control on document reviewing and approvals at multiple workflow statuses, making the updated versions available for all users that assist the organization and auditors make effective decisions. Also, it promotes customer focus, manages new inventions, helps to understand issues from the bottom line, reduces human errors, and provides AI (Artificial Intelligence) analytics.
Increasingly Strict Compliance Regulations
The increasing quality issues, product recalls, and complexity of medical devices have made compliance regulations reflect and produce the new regulatory standards that are more stringent but harder to interpret. Though it is for a clear cause, it became a constrain for the medical device manufacturers to stay up in the market.
The main reason for the medical device manufacturing industries getting a warning letter from the FDA 21 CFR Part 11/device compliance regulation is the inadequate complaint procedures. The complaints received from consumers by any communication means – electronic, written, digital or oral need to be appropriately received and addressed through a streamlined process involving investigation, root cause analysis, implementation, and validation process and are documented for retrieval when inspection needs.
Process Validation Hiccups
The medical devices are designed to protect health care measures and to offer improved patient safety. With that tag, it’s understood that the manufacturers are prone to FDA and other medical device regulatory body inspections. The quality leaders should be prepared with detailed documentation for audits at any point in time, be it internal or external.
To be successful, comply with the FDA regulations, capture and record minute details associated with quality processes, and manage and secure documents for better traceability and accuracy.
Documents Linking and Approvals
Identifying the issues is a straightforward process as it’s raised as a request of complaint or non-conformance. Getting to the root cause of a problem is challenging, especially when the complaints and non-conformance process is carried out on paper. The device regulatory compliances adhere to series of approvals with the designated signatory on the process followed. Relying on paper documents for approvals and analysis introduces duplicate copies, human errors, and delayed product launches leading to disconnected/distracted product records making it harder to avoid quality issues and defective products.
A product-centric quality management system can help organizations with automated processes via paperless document management, ensuring connectivity of production processes and continuous quality improvements. The QMS provides 360-degree visibility of records across authorized teams with e-signatures in place for the designated team to approve. It also enables the users to determine the RCA more efficiently and quickly to produce safer and reliable regulatory compliant devices. This is possible only when the documents are linked.
Handling CAPA’s
CAPA’s – Corrective Actions and Preventive Actions involves a series of workflow stages from identification and investigation through analysis and preventive measures. The FDA/ISO regulatory standards are there to produce quality medical device products. This requires the manufacturers to streamline the CAPA process in line with the compliances. Many manufacturers have unhealthy or loosely connected CAPA’s, making it challenging to implement practical corrective and preventive actions to fix future product quality issues. To handle CAPA’s, the quality leaders require a sound and transparent quality management system capable of capturing an issue instantly, identifying the cause, investigating the problem, analyzing the root cause, implementing improvements, and close resolutions involving continuous monitoring and validation process. Such a streamlined quality process helps to prevent non-conformances, defects, and product failures, with fewer CAPA’s on board.
Concluding Thoughts
Having a clearly defined design and development process with efficient requirements planning is vital for medical device industries to succeed in the competitive market. Achievement only happens with a good QMS in place.
eQMS is a cloud-based Quality Management platform that enables a paperless in-compliant audit-ready automated process for the medical device industries to deliver quality, life-altering products.
To know more about integrating the latest technology and AI with quality processes to enable you to develop high-quality products, schedule a demo with us, and help you rule the regulatory market competitively.
Connect with Compliance Group today at sales@complianceg.com or call (847) 327-3167, Ext. 406.
FAQ's
What is regulatory compliance in medical devices?
Companies in the medical device industry have an unprecedented impact on human health. Hence, Medical device companies are in the scope of various global regulations, many of which govern how products are made and how they make it to market. The regulations have diverse and unique requirements. These include communicating substances in products to downstream users and consumers, restricting products above a certain threshold, certifying medical devices by notified bodies, and reporting substances in articles into a central database. Companies must meet the requirements of these regulations and many others to keep their products on the market.
In addition to these substance requirements, medical device companies may have corporate social responsibility requirements to meet. For example, many also voluntarily report human trafficking, slavery, and responsible mineral sourcing to meet stakeholder expectations and add value to their brand.
What are the four key compliance issues categories?
Every year, the number of non-compliance issues handled by the FDA seems to crop up. Below listed are the key compliance issues:
- CAPA – Corrective Action and Preventive Action – The most commonly cited non-compliance issue. Mostly, the companies fail to establish corrective and preventive actions and do not document the processes correctly.
- Complaint Procedures – Every organization should follow robust, compliant procedures defined by the regulatory body. Failing to comply with inadequate complaint procedures is the second most common compliance issue.
- Medical Device Reporting Procedures – This is another common violation by most medical device companies. They fail to document or lack written processes and procedures and omit critical descriptions and implemented resolutions.
- Non-Conformances – Control of Non-Conformances. Every organization should adequately describe the occurrences and causes of non-conformances and document the corrective measures.
What does regulatory do in medical devices?
Under the regulatory rule 21CFR, Parts 800-1299, the FDA imposed guidelines for the medical device companies to comply with regulations. Thus, the regulatory board serves a critical function throughout the device/product life cycle, from pre-market strategies like device designing and manufacturing to postmarket compliance.
Are medical devices FDA regulated?
Yes, the Center for Devices and Radiological Health (CDRH), a branch of the FDA, regulates medical devices and radiation-emitting products.
How does a medical device get FDA approval?
There are three basic processes by which a medical device company can obtain FDA approval for marketing their manufactured medical devices. The approval process depends on the conditions of the approval is sought for
- PMA Process – Pre-Market Approval process
- PMN Process – Pre-Marketing Notification process
- HDE Process – Humanitarian Device Exemption process