Beyond Compliance: unlocking therapeutic quality excellence  🖥️  💊 💉 16-18 January

Join our virtual event
  • THE QUALIO PLATFORM

    • icon-nav_Check ring
      Product Overview

      #1 eQMS for life sciences

    • icon-nav_Cursor
      Product Tour

      Click through an interactive demo

    • icon-nav_File
      Documents

      Digitize and organize your entire stack

    • icon-nav_Subttasks
      Design Controls

      Drive a faster and stronger route to market

    • icon-nav_Info
      Risks

      Pinpoint, prevent & resolve risks

    • icon-nav_Users
      Training

      Track and demonstrate competence

    • icon-nav_Pencil
      Change Control

      Manage any change easily & effectively

    • icon-nav_Chield
      Audits

      Become 100% audit-ready

    • icon-nav_Chart
      CAPAs & Nonconformances

      Drive continuous improvement

    • icon-nav_Bag
      Suppliers

      Manage suppliers with ease

    • icon-nav_Pie chart
      Analytics

      See your quality landscape at a glance

    QUALIO+ SERVICES

    Have quality and regulatory experts on your side.

    Learn more
    icon_product-callout
  • OUR SOLUTIONS

    • icon-nav_Setting
      Solutions overview

      An integrated eQMS to help you hit your goals

    • icon-nav_BPM
      Medical Devices

      Get to market faster with unshakeable quality

    • icon-nav_Laptop
      Paper to eQMS

      Ditch the clutter and chaos by going digital

    • icon-nav_Laptop
      Software as Med Device

      Embed quality into the core of your SaMD development

    • icon-nav_Chield
      ISO compliance

      Meet your requirements from 9001 to 13485

    • icon-nav_Drop
      Pharmaceuticals

      Build a world-class pharma quality system

    • icon-nav_Ticket
      CE & UKCA marking

      Bring your medical device to the EU and UK

    • icon-nav_DNA
      Biotech

      Drive life-saving, industry-leading products

    • icon-nav_Star
      FDA clearance

      Unlock the US market by satisfying the FDA

    • icon-nav_Plant
      Cannabis

      Grow regulatory trust and distribute with confidence

    • Blank

    • icon-nav_List
      Contract Research Orgs

      Provide compliant, quality-driven life science services every time

    QUALIO INTEGRATIONS

    Qualio integrates with your key business critical applications.

    See integrations list
    icon_solutions-callout
  • CUSTOMER SUCCESS STORIES

    • icon-nav_Sound
      Customer Stories

      Learn how companies like yours use Qualio

    • icon-nav_Heart
      Customer Reviews

      Hear what our customers say about us

    • Headphones-1
      Customer Reference Program

      Love Qualio? Spread the word!

    QUALIO G2 REVIEWS

    Learn why we have been ranked the quality management platform of choice.

    See G2 reviews
    icon_customers-callout
  • EXPLORE OUR RESOURCES

    • icon-nav_Archive
      Content Library

      View guides, toolkits, podcasts, and more

    • icon-nav_Chat
      Qualio Blog

      Access tips, tools and insights from real quality professionals

    • icon-nav_Calendar
      Events & Webinars

      Join us at our online & in-person events

    • Headphones-1
      Podcast

      Hear quality lessons and conversations from the industry

    CALCULATE YOUR ROI

    See how much money Qualio can save you by sharpening your quality processes

    Get your ROI
    icon_roi-callout
  • ABOUT US

    • icon-nav_logo
      Company

      Learn about our company, people & investors

    • icon-nav_User+1
      Careers

      Come join the team

    • icon-nav_Star
      Partners

      Become our partner today

    • icon-nav_Email
      Contact

      Get in touch with us

    BRANDED ASSETS

    If you're looking to apply our brand somewhere, we have put together a media kit for you.

    Download media kit
    icon_about-callout
  • Pricing
  • Request a demo
    Login
Request a demo
Login
Return to blog

    All articles from Sumatha Kondabolu

    FDA
    • July 03, 2023

    21 CFR Part 820: the complete overview

    Read article
    Quality management
    • June 26, 2023

    The hidden costs of a free quality management system

    Read article
    Medical Devices
    • May 24, 2023

    The TGA's essential principles explained

    Read article
    Medical Devices
    • May 10, 2023

    The complete guide to passing ISO 13485 audits

    Read article
    510(k)
    • January 30, 2023

    510(k) submission checklist to get your medical device to market

    Read article
    FDA
    • January 25, 2023

    The 3 FDA medical device classes: differences and examples explained

    Read article
    Audit
    • January 16, 2023

    Complete guide to the MDSAP's nonconformity grading system

    Read article
    21 CFR Part 11
    • January 02, 2023

    A comprehensive review of the best 21 CFR Part 11 software in 2023

    Read article
    Medical Devices
    • November 30, 2022

    What the FDA's new MDDS guidance means for you

    Read article
    Sumatha Kondabolu
    Sumatha Kondabolu

    Sumatha has 19 years of QA/RA experience across the medical device and pharmaceutical sectors.

    She has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDD and IVDR.

    She holds a Master’s in Chemistry and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, ISO 9001 and IATF 16949.

    Follow me on LinkedIn

    Topics

    • FDA
    • Quality management
    • Medical Devices
    • ISO 13485
    • 510(k)
    • Medical device/SaMD
    • Audit
    • 21 CFR Part 11
    Qualio Logo

    How much is your legacy quality system costing your business?

    Use our ROI calculator to see the cost savings of an eQMS in seconds

    Get your ROI figure
    • Product
      • Product overview
      • Documents
      • Design controls
      • Risks
      • Training
      • Change control
      • Audits
      • CAPAs & non-conformances
      • Suppliers
      • Analytics
      • Qualio+ services
      • Product tour
      • Pricing
      • Integrations
      • Competitors
    • Solutions
      • Solutions overview
      • Paper to eQMS
      • ISO compliance
      • CE and UKCA marking
      • FDA clearance
      • Medical devices
      • Pharmaceuticals
      • Biotech
      • Cannabis
      • Software as medical device
      • Contract research orgs
    • Customers
      • Customer stories
      • Customer reviews
      • G2 reviews
    • Resources
      • Content library
      • Qualio blog
      • Press room
      • Events
      • Podcast
      • ROI calculator
    • About
      • Company
      • Careers
      • Partners
      • Contact
      • Quality policy
    • Legal
      • Terms of service
      • Privacy policy
    • Social media

    © Qualio — QMS for Life Sciences

    ISO 9001 ISO 27001