Medical Devices

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Medical devices play a vital role in maintaining the health of individuals. Right from common medical procedures – from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial hip or any surgical intervention – would not be possible.

Based on the risk, FDA classifies medical devices into 3 classes

  • Class - 1 (Low risk)
  • Class - 2 (Medium risk)
  • Class - 3 (High risk)

With ZenVector™, the industry can take care of the following challenges

  • Quality concerns
  • Supply chain challenges
  • Regulatory challenges
  • Cybersecurity challenges
  • Lack of effective collaboration within workforce

Problems Faced

Quality Problems

  • In the last 4 years, 110 medical devices were recalled due to poor quality and safety issues. Manual paper-based quality event procedures are prone to errors. Without a robust Quality management system, production results in highly varied outputs, thereby resulting in increased product recalls
  • Employees spend only 5-10% of their time reading the documents and 50% of their time looking for critical documents. Sharing documents to different departments within the organization is extremely complicated, and it becomes even more complex if the company has global sites
  • 191 Warning letters have been issued to the medical devices industry in the past 4 years. An increase in the warning letters results in increased approval timelines, as well as loss of reputation
  • All class 3 and some of the class 2 device manufacturers need to show clinical trial data for premarket approval. It is difficult to maintain all trial subject’s data and clinical protocols manually. If the trails are multisite, for sponsors it is difficult to maintain all trial related data

R&D Problems

R&D captures experiment data in hardcopy note books, which makes it difficult to search for and archive information. It also increases dependency on individuals to conduct the experiment.

Without digitalization, maintaining complex workflows and sample tracking in workflow is difficult. Managing the complex data by using manual analyses methods can sometimes lead to errors. Tracking of equipment maintenance schedules and keeping all equipment calibrated is complicated. Ensuring timely communication between all stakeholders of an experiment is challenging.

How A.i.zen Algo Pvt. Ltd. can Help

Quality Management System for Medical Devices Industry

QualZen™ enables medical devices industry users to manage all the quality events on a digital platform, including initiation and managing the workflows. Its intuitive workflow allows users of medical devices companies to investigate the quality event and enable review by peers. The dynamic dashboards empower the management to visualize the ongoing, pending and completed quality events, to product defect-free, good quality safe products, which are in compliance with the specifications for the medical devices industry.

Document Management System for Medical Devices Industry

DocuZen™ enables the authors in the medical devices industry to create the document, engage with other authors across the globe, and then put the document through global peer review workflow. Digitalization can help the medical devices companies reduce document review cycles by 65% and save 35% costs on average. The document can be made available to all users once is it peer-approved. The documents are easily searchable through keywords.

Audit Management System for Medical Devices Industry

AuditZen™ effectively manages all the warning letters information (Observations & Responses) of the clients in the medical devices industry. There is a complete audit trail of each step, keeping the organization 100% audit ready. During internal audits auditors can focus on the existing observations to avoid the repetition of same ones.

Clinical Protocol Automation for Medical Devices Industry

ClinZen™ helps the medical devices industry to maintain transparency in clinical trials across various sites and collaborators. ClinZen™ effectively manages the trial subject’s data with end-to-end trail.

eLab Notebook for Medical Devices Industry

NoteZen™ enable medical devices industry users to easily search the experiments by giving keywords and download the reports if required. In NoteZen™, experiments are structurally arranged in folders & the users can even collaborate with others globally.

Laboratory Information Management System for Medical Devices Industry

LabZen™ enables medical devices companies to easily track the raw materials and samples used in batch execution, and results can be effectively managed against specifications, along with automated approval. All the tests performed on the batch at every stage can be managed, providing a complete end to end Laboratory Workflow management.

Our Products Deployed in industry


Quality Management System

Intelligent quality system that ensures compliance Know More


Document Management System

Smart, interactive and predictive framework Know More


Audit Management System

AI/ML enabled system for 24x7 audit readiness Know More

ClinZen™(Coming Soon)

Clinical Automation

Automated end-to-end clinical workflow Know More

NoteZen™(Coming Soon)

Electronic Lab Notebook

Smart, interactive and intuitive lab notebook Know More

LabZen™(Coming Soon)

Laboratory Info Management System

Automated, ML enabled laboratory workbench solution Know More

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