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    Whitney Lewis
    Quality Assurance Specialist at Blackrock Microsystems
    November 2018
    How to determine when to label a medical device as investigational use only
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2019
    Device Calibration and Public Health and Safety
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2019
    Need a job? Distribution? Money? Do this first.
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    May 2015
    Change Control Effectiveness Checks
    Danny Kroo
    ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
    December 2018
    What are the regulatory requirements for selling first aid kits in the USA?
    Dr Kalina Tonigold
    Regulatory Affairs & Quality Management Specialist at ARRI
    October 2016
    Qualified Person (QP) in the field of medical devices
    Anne T.
    Analyst and scientist for biotech investment
    December 2016
    How to file to FDA for a 510k exempt device?
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2016
    ISO 147971 Update with Annex ZA
    Thomas Cronin
    Quality and Compliance Engineer at Ushio America, Inc.
    October 2015
    Question on EU lifetime testing
    Ong Kean Seng
    Senior Manager Regulatory Affairs at InQpharm
    September 2018
    Is QMS certification an EU must to obtain CE marking
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