edeng, Author at Medgadget Medgadget

edeng

Author's Posts

Releases

Health2Sync Strategically Partners with Taiwan’s Ministry of Health and Welfare in Asia’s First Government Supported Online Diabetes Care Program

October 18th, 2016 Taiwan Takes First Initiative in Launching Online Care Program in Battling Growing Prevalence of Diabetes Taipei, Taiwan - October, 18th, 2016 - Taiwanese startup Health2Sync announced their strategic partnership with Taiwan’s Ministry of Health and Welfare (MOHW) in bringing online diabetes care...

Releases

Digital Health Startup Health2Sync Raises $3M Series A to Transform Diabetes Care

August 23rd, 2016 With Proven Clinical Efficacy, Health2Sync Aims to Bring Personalized Care to Patients in Asia Taipei, Taiwan - August, 30th , 2016 - Taiwanese startup Health2Sync secures a $3 million Series A investment led by WI Harper Group; with participation from Cherubic Ventures, iSeed Ventures, and SparkLabs Global...

Upcoming conferences

october

18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

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

Event Details

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.

Time

october 18 (Thursday) - 19 (Friday)

Organizer

Compliance Online 80068SEM

Learn More

Calendar GoogleCal

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