Refine by
Locations
- USA
- Alabama
- Alaska
- Arizona
- Arkansas
- California
- Colorado
- Connecticut
- Delaware
- District Of Columbia
- Florida
- Georgia (Us)
- Hawaii
- Idaho
- Illinois
- Indiana
- Iowa
- Kansas
- Kentucky
- Louisiana
- Maine
- Maryland
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- Missouri
- Montana
- Nebraska
- Nevada
- New Hampshire
- New Jersey
- New Mexico
- New York
- North Carolina
- North Dakota
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Vermont
- Virginia
- Washington
- West Virginia
- Wisconsin
- Wyoming
Iso 13485 Software In Usa
11 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: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: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 ...
Manufactured by:Renishaw plc based inGloucestershire, UNITED KINGDOM
Simplifying and streamlining the production of customised CMF/OMF implants and guides. No two patients are the same, so why should their implants be the same? Customised implants allow for personalised healthcare, helping to ensure each patient gets the very best ...
by:Honeywell | Life Sciences based inHamilton, NEW JERSEY (USA)
Medical device manufacturers must comply with 21 CFR Part 820, medical device reporting (MDR), premarket notification 510-(k), investigational device exemption, and quality system (QS) regulations. Audits help manufacturers to improve quality, lower costs, and increase compliance. But, managing them manually can become a time and resource intensive ...
Manufactured by:Syncro Medical based inLanghorne, PENNSYLVANIA (USA)
Whether your product is a wearable, implantable, or a classic bedside monitoring system, Syncro’s long-standing experience developing monitors is a powerful benefit to you and to your ...
Manufactured by:Syncro Medical based inLanghorne, PENNSYLVANIA (USA)
Mobile is the new frontier for medical instrument innovation. The FDA describes current applications as “just the tip of the iceberg in a coming revolution in mobile medical applications.” We agree, and we stand ready to help your company be a leader in this ...
by:Indica Labs Inc. based inAlbuquerque, NEW MEXICO (USA)
HALO Prostate AI, from Indica Labs, is a CE-IVD certified deep learning based screening tool designed to assist pathologists in the identification and grading of prostate cancer in core needle biopsies. The algorithm automatically analyzes all appropriate case slides and notifies pathologists of cases with suspected findings directly in their native ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
Document change control software is essential for ensuring compliance and managing change in regulated industries such as life sciences and manufacturing. By utilizing this software, companies can effectively address the complexity of change control and streamline their ...
Manufactured by:Nextern Inc based inWhite Bear Lake, MINNESOTA (USA)
We are your sole partner to provide seamless connected medical device development solutions. Leveraging our experience and expertise in medical device design, cloud architecture, and mobile engagement ...
by:BrightInsight, Inc based inSan Jose, CALIFORNIA (USA)
The leading global regulated Digital Health platform for biopharma and ...