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Iso 13485 Software
41 software items found
by:Vintara based inOakland, CALIFORNIA (USA)
Vintara’s Enterprise Portal helps leaders deploy world class best practices for the manufacture and sale of medical devices. Our configurable workflow applications will drive performance and world class regulatory compliance including: ISO 13485, 21 CFR Part 11 compliance, 21 CFR Part 820 compliance, CAPA, Device Master Records, Customer Complaints, ...
by:AQA Company, Inc. based inLa Canada, CALIFORNIA (USA)
4-product bundle with all you need to implement ISO 13485 and/or FDA ...
by:AQA Company, Inc. based inLa Canada, CALIFORNIA (USA)
Electronic signatures (part 11), document approval process, document distribution module, due/past due record alerts, tasking, messaging and emailing, data filtering and export, bulk data import, user and group permissions, password security policies, audit trail (part 11), remote ...
by:qmsWrapper based inToronto, ONTARIO (CANADA)
Forget all those repetitive and time-consuming tasks and small processes that end up taking an unreasonable amount of time and energy. qmsWrapper now provides Custom Issue Forms as a new driving force of your workflow. Now you can make a custom web template according to your needs, or as per requirements of the standard ISO 13485: 2016 or any other that your ...
Manufactured by:Softeq Development Corp. based inHouston, TEXAS (USA)
Our team of experts will help you navigate the stringent healthcare security standards, including FDA, HITRUST, HIPAA, HL7, DICOM, and ISO ...
by:Xybion Corporation based inPrinceton, NEW JERSEY (USA)
Designed for today’s digital world, CQRM is a low-code software that helps businesses operating in regulated industries manage compliance, risk, and quality. The powerful cloud-based software facilities organizational compliance with regulatory guidelines such as: ISO 9001, ISO 13485, ISO 17025, ISO14001, GxP, 21 CFR Part ...
by:Ambient Clinical Analytics based inRochester, MINNESOTA (USA)
AWARE reduces information overload by filtering for relevant patient data and providing best care practices for improved patient outcomes. The AWARE™ software platform has achieved FDA Class II clearance, CE Marking, and ISO 13485:2016 certification. By providing predictive analytics in healthcare, AWARE™ decreases provider fatigue, reduces errors, ...
by:Omnex Inc, USA based inAnn Arbor, MICHIGAN (USA)
Effectively tracking issues, concerns, and knowledge are part of an organization's continual improvement strategy. When an issue is raised by a customer, management will want to receive status updates on whether the concerned team has started working towards resolving it on priority. Omnex’s Problem Solver aids as a common tool and knowledge bank to track, manage, and resolve problems. ...
by:qmsWrapper based inToronto, ONTARIO (CANADA)
With qmsWrapper it’s easy to keep your commitment to quality, by combining Project and Quality Management together as one. Projects woven through quality are smart management that effectively avoids adding another layer of management and bureaucracy to the daily work. QMS Processes driven by Project Management ensures the projects are managed in a most efficient way. That’s Managing ...
by:Vintara based inOakland, CALIFORNIA (USA)
People. Process. Technology. At Vintara, we have developed a solution that combines the power of these three key elements to streamline your path to ISO 9000 compliance. The alliance of our powerful Web-based application, comprehensive service offerings and tailored process is all you need to successfully build a fully integrated Quality Management System ...
by:Omnex Inc, USA based inAnn Arbor, MICHIGAN (USA)
Document Pro is a single repository to manage all your business documents and records. You can monitor employee access, document revisions, change requests, and approvals through an online platform. Documents can be customized into infinite number of levels and folders per structural requirements. The system follows a pre-programmed base structure in which; Level 1 is for Quality Manual, Level 2 ...
Manufactured by:IUL S.A. based inBarcelona, SPAIN
We provide our iPeak® Partners a secure ecosystem equipped with data connectivity with HL7 to export your OEM or off-the-shelf iPeak® data to LIMS; LIS, HIS, EMR or any ...
by:Omnex Inc, USA based inAnn Arbor, MICHIGAN (USA)
AQuA Pro is the first Advanced Product Quality Planning (APQP) software released in the mid 1980s. This integrated, web-based database management application creates, maintains, analyzes, and organizes APQP, PPAP and other product realization documentation. We adopt a best-in-class step by step approach towards automating and documenting the APQP process. This APQP process defines and documents ...
by:Omnex Inc, USA based inAnn Arbor, MICHIGAN (USA)
BOSS® or Business Operating System Software® enables companies to apply a logical order to operational data. Generally, companies are data-rich and analysis-poor. When available data is overlooked, it is difficult to formulate solutions and maximize a company's full potential. BOSS® provides data structure for problem-solving and decision analysis in easy-to-read formats. With BOSS, ...
Manufactured by:ARANZ Medical Limited based inChristchurch, NEW ZEALAND
Silhouette Home User enables patients to easily and securely take images and record notes on their mobile devices without leaving home. The patient’s assessment information is instantly available for their healthcare provider to review and assess on SilhouetteCentral. ...
by:Cority based inToronto, ONTARIO (CANADA)
Medgate’s Quality Management Software will transform how you manage your quality system. Achieve excellence by streamlining and integrating your processes. For three decades, Medgate has helped hundreds of manufacturers connect and empower their people with processes and technology across the value chain. The software provides an accessible, simple-to-use way to drive ...
by:isoTracker Solutions Ltd. based inLondon, UNITED KINGDOM
Document control that’s easy, consistent and cost-effective. isoTracker’s document management software makes it simple to comply with document control standards. It also saves time and eliminates mistakes. The module can stand alone or integrate with our other quality management ...
by:isoTracker Solutions Ltd. based inLondon, UNITED KINGDOM
Make complaint handling consistent, effective, and easy. Our cloud-based complaints management system ensures that every complaint is properly recorded, assigned, tracked, and resolved. The module can stand alone or integrate with our other quality management ...
by:qmsWrapper based inToronto, ONTARIO (CANADA)
qmsWrappers Traceability Matrix has an innovative and unique approach to manage complex medical device products. Traceability is required by regulations and this tool helps you stay ...
by:VIDA Diagnostics Inc. based inCoralville, IOWA (USA)
VIDA provides quality, quantitative CT imaging analysis for all major lung and respiratory diseases to streamline clinical trials with leading ...