• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Cancer Organoids Offer Insights into Treatment Outcomes

      Cancer Organoids Offer Insights into Treatment Outcomes

      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Laser-Based Breath Analysis Detects COVID-19 Infection

      Laser-Based Breath Analysis Detects COVID-19 Infection

      Technique Reveals 3D Genome Interactions

      Technique Reveals 3D Genome Interactions

    • Radiology
      Implanted Ultrasound Lets Chemo Access Brain

      Implanted Ultrasound Lets Chemo Access Brain

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

      RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

    • Cardiology
      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Chest Wearable Provides Key Heart Measurements

      Chest Wearable Provides Key Heart Measurements

      Vein on a Chip Includes Flexible Valves

      Vein on a Chip Includes Flexible Valves

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

    • Surgery
      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Stimulating Wounds with Electricity for Rapid Healing

      Stimulating Wounds with Electricity for Rapid Healing

    • Nanomedicine
      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Get Lymphatic Vessels Pumping

      Nanoparticles Get Lymphatic Vessels Pumping

      Bottlebrush Particle for Synergistic Drug Combinations

      Bottlebrush Particle for Synergistic Drug Combinations

    • Military Medicine
      Wearable Can Take Multiple Sweat Samples

      Wearable Can Take Multiple Sweat Samples

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

    • Rehab
      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

Two-Day Interactive Course on In-Vitro Diagnostics Regulations

August 22nd, 2018 ComplianceOnline Sponsored Content

In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.

This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.

Learning Objectives:

After completion of this two day interactive course on IVD, the attendee will be able to:

  • Understand why IVD is regulated differently.
  • An overview of IVD Regulations – U.S. FDA., Europe (MDD), Canada.
  • Develop Regulatory Strategies and determine Regulatory Pathways.
  • Inclusion and exclusion of data and information for different submission.
  • Format and Content of premarket submissions.
  • Product Label and Labeling for IVDs.
  • Working and interacting with the reviewers and regulators.
  • Tips and Suggestions to secure rapid regulatory approvals.

Speaker :

Dave Kern has 25+ years in the life sciences and medical device industries, holding positions in Product Development, Program Management, Alliance Management, and most recently, Regulatory Affairs. Before starting K2 Regulatory Consulting, he was Head of Regulatory Affairs and Clinical Affairs at Illumina, where he built a global organization, with offices in China, Australia, and the UK. He also led the regulatory efforts to bring Illumina their first PMA product approval (Extended RAS Panel Test) in 2017.

Learn more and register…

ComplianceOnline

At ComplianceOnline, we are focused on: Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety. Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns. Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally. Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

Sponsored

Packaging Compliance Labs (PCL) Celebrates Site Expansion in Grand Rapids, MI

Novel Approach to Assessing Lung Function Enables Improved Detection, Diagnosis and Treatment Decisions in Subject Exposed to Military Burn Pits

U.S. Patent Office Grants Additional Patent Protection For  Exoskeleton Focal-Force Angioplasty Platform

U.S. Patent Office Grants Additional Patent Protection For Exoskeleton Focal-Force Angioplasty Platform

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

interviews & reviews
Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Imagene Profiles Cancer Biomarkers in Real Time

Imagene Profiles Cancer Biomarkers in Real Time

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email