Qualio+
Quality-as-a-Service

Best-in-class eQMS software plus
templated content and expert support
to maximize your quality maturity

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Ready-to-go regulatory content

Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.

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Powerful software

Build a world class eQMS that embeds lasting compliance, from documents and design controls to training and events.

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Quality assurance
experts

Work with our team of seasoned quality experts to ensure you meet - and exceed - your QA goals every time.

OUR QUALITY TEAM

Meet your quality support team
The Qualio+ team combines commitment to your success
with a century of combined life science quality experience.
Jerry

Jerry has 15+ years of experience in pharmaceutical, biotechnology and diagnostic laboratory environments.

 

He joined Qualio after 3 years consulting for the CDC.

 

Jerry Adatsi

Manager of Quality Services

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Lola is an ASQ Certified Medical Device Auditor with extensive experience working for large multinational corporations and start-ups across Europe and North America.

She works closely with customers to implement and maintain their eQMS, helping them to achieve their quality goals and bring their product to market efficiently.

Lola Furlong

Senior Quality Specialist

Jason Pic

Jason has 14 years of experience in quality and regulatory roles within the medical device industry.

Jason has worked with a string of global regulations and standards, and brings with him a vast knowledge of FDA and ISO 13485 requirements.

Jason March

Senior Quality Specialist

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Casey has 10+ years of quality experience working in the pharmaceutical and medical device sectors.

She is also skilled in auditing and specializes in FDA, ISO 9001 and ISO 13485 regulations.

 

Casey Wise

Quality Specialist

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Molly brings 8 years of quality knowledge from the pharmaceutical, medical device and laboratory fields.

Molly is particularly experienced with FDA, HPRA, MDSAP and ISO 13845 audits.

 

Molly Calvey

Senior Quality Specialist

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Sumatha has over 20 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 27001, ISO 17025, ISO 9001 and IATF 16949.

Sumatha Kondabolu

Senior Quality Specialist

Qualio+ resources

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Datasheet

Dive into our Qualio+ offering and learn how your business benefits.

Get my datasheet
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Webinar

Watch our walkthrough webinar to hear about Qualio+ straight from the team that runs it!

Watch the webinar

Templated content for accelerated compliance

Access pre-built eQMS document templates, expert support to apply them
and integration with your existing quality management structure

Content

For businesses independently building their eQMS from scratch with templated content

  • Industry-ready eQMS document templates
  • Quality & compliance support & guidance
  • Legacy QMS analysis & integration

Greenfield

For businesses needing support to apply and adapt their new templates

  • Industry-ready eQMS document templates
  • Quality & compliance support & guidance
  • Legacy QMS analysis & integration

Hybrid

For businesses integrating templates into an existing quality management structure

  • Industry-ready eQMS document templates
  • Quality & compliance support & guidance
  • Legacy QMS analysis & integration

Add-ons

Additional support projects led by seasoned life science quality veterans

  • QMS gap assessment
  • QMS audit
  • Document gap assessment
  • eQMS content tailoring
  • GxP training
  • Quality/regulatory support session

Hear from our happy Qualio+ customers

Real quality folks. Real help. Real results.

Hallie Greene ViQi
Hilary Baldwin SimBioSys
Heather Underwood EvoEndo
DON'T TAKE JUST OUR WORD FOR IT

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