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February 25, 2020

Rapid innovations and emerging technologies in the medical device industry have triggered changes in the regulatory landscape with the release of new mandates and modification of existing ones. Organizations operating in the space must now ensure geo-specific compliance and prompt response to emerging regulatory drivers. These continually evolving regulatory needs can be addressed by new age technologies like Artificial Intelligence (AI) and Machine Learning (ML) and help organizations transform the processes to ensure highest standards of compliance.

However, in order to take that first step in the direction, the organizations will need to begin by investing in a cost-effective integrated regulatory framework that supports the proof of compliance. While there are many use cases of AI and ML in the sector, it is important to understand all the granularities and prioritize accordingly.

Technology can help bridge many-a-gap for the firms operating in the segment by ensuring required vigilance to evolve according to the compliance needs. Some of the areas of deployment include maintaining a dynamic repository for regulations, managing data, and offering alerts for any changes. Here are some areas, we think, technology can help streamline for the medical device companies going forward.

  • 360-degree view: An AI-based application can easily maintain a repository of global regulations and guidance documents. It can provide updates on upcoming regulations, information regarding regulatory pathways for a specific geography, and a comparison of different geo-specific regulations.


  • Creation and submission of documents: With the aid of Natural Language Processing technology, AI-based solutions can extract information from journals, regulatory databases, document management systems (in-house) and various other texts to create documents for regulatory submission (Tech File, 510K application, Clinical Evaluation Reports). This renders speed and accuracy to the process. An AI/ML-based solution can further be leveraged to auto-submit related documents to regulatory agencies for market clearance.


  • Round-the-clock compliance check: Instead of conducting periodic offshore and onsite audits, AI/ML-based regulatory solutions can constantly monitor processes, products, and supply chains to ensure alignment with product-specific standards, information security, and regulatory requirements. This helps companies proactively work on the non-conformities and prevent hefty fines.


  • Risk assessment: AI-based applications can analyze multiple data sources to provide real-time alerts on the risks to patient safety from the products, as well as threats related to security during the product sustenance phase. They can also analyze various other industries and suggest applicable risk control measures to be implemented during the design and development phase. It can also offer suggestions about corrective and preventive actions for non-conformities.


  • Automation of repetitive manual tasks: Regulatory compliance involves submitting documented evidence in a standard format. The documents could pertain to either obtaining market clearance (Pre-Market Application, 510K application, Summary of Technical Documentation, filing a product failure report - Form 3500A), or product post-market summary report. In either case there is need to collect data from manufacturers’ PLM systems, document management systems and CAPA systems, industry websites, literature websites, and regulatory databases, etc. This is a manual task and often repetitive, based on the iterative model of the product developed. Hence, automating the task - with the help of AI - can reduce time, effort, and errors.


The way forward

The best part is that the medical device industry will not be the first to automate compliance processes. Finance, another highly regulated sector, has already found value in automating the regulatory frameworks. It is time the medical device industry learns from the use cases in these sectors and applies them to their benefit. Besides being cost-effective, automation can improve processes and workflows, and enable post-market surveillance with faster resolution.

In fact, we can imagine a day, not too far away when AI-based regulatory applications can handhold the person responsible for regulatory compliance (PRRC) to perform their roles and responsibilities more diligently.


Anita Ramachandran has over 25 years’ experience in Medical Device Industry working as Regulatory and Quality Consultant. She is part of EIS-Medical Device Group working for Regulatory solution CoE. She helps in providing consultancy on various geography specific regulations and guidance, software process standards, verification & validation, security assurance, Software as Medical Devices and Digital Health program. Anita’s specialization includes Quality Management, Regulatory Strategy definition, Risk Management, CSV / OTS Validation, Software / System Verification and Validations, Project Remediation’s, Process improvements, DHF / Design Dossier Creation, 510 (K) / Technical File Submissions, Audits and Training. Her present focus is on keeping abreast with the regulations around the digital health program, cybersecurity in Health IT. Anita also guides in development of In-house Tools, framework / Methodology and PoCs in medical device regulatory space.


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