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