Qualio+
Quality-as-a-Service

Best-in-class eQMS software plus
expert quality assurance support to help you
get to market faster.

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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.
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Kelly leads Qualio’s in-house quality team and spearheads our Qualio+ offering.

Kelly has amassed over 20 years of experience working with quality teams at Abbott, Sandoz, Cochlear and more, before becoming Qualio's Director of Quality.

Kelly Stanton

Director of Quality

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 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.

Sumatha Kondabolu

Senior Quality Specialist

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Tatyana has operated in the laboratory research and clinical testing industry for over 10 years.

She holds a Bachelor of Science in Biology and a Master of Science in Biotechnology. Her previous experience includes laboratory leadership, clinical quality, auditing and clinical trials. 

Tatyana Santoke

Senior Quality Specialist

Qualio+ resources

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Qualio+ datasheet

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

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Best practice quality management

Choose the support you need from our QA experts.

Qualio+

Tailored and targeted expert support from our team of quality assurance advisors to help you hit your quality objectives.

  • ISO/FDA audit-ready eQMS
  • Strategy sessions
  • QA support
  • eQMS training
  • Market intelligence

Audit Program

Preparing for an audit? Leverage our new Audit Program alongside, or independently of, our main Qualio+ offering.

  • 2 x gap assessments
  • 1 x internal QMS audit
  • 4 x critical supplier audits
  • Detailed reports and checklists
  • Auditor training
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