Welch Allyn Connex Clinical Surveillance System for Continuous Multiple Parameter Patient Monitoring

February 13th, 2014 Editors Cardiology, Critical Care, Emergency Medicine, Medicine, Surgery

Welch Allyn has partnered with other big names in vital signs monitoring to introduce the Connex Clinical Surveillance System, an integrated set of tools designed for watching patients in medical-surgical environments. The system is built around the Welch Allyn Connex Vital Signs Monitor, which is connected to a Masimo acoustic respiration cloth sensor that detects breathing, a Covidien MicrostreamCO2 monitoring device, and the EarlySense technology that detects the heart rate, breathing rate, and patient through a contact-free panel positioned under the mattress.

All the data from the monitoring systems is fed live into a unified display station as well as the hospital’s electronic medical record, and abnormal readings can be programmed to trigger alarms to warn clinical staff.

Press release: Solution Designed Specifically for Med/Surg Floors Addresses UnmetPatient Surveillance Needs in Hospitals…

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18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

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Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

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october 18 (Thursday) - 19 (Friday)

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Compliance Online 80068SEM

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18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada