Ready-to-go regulatory content
Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.
Powerful software
Build a world class eQMS that embeds lasting compliance, from documents and design controls to training and events.
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.
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 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
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 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
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
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
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
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
Qualio+ datasheet
Dive into our Qualio+ offering and learn how your business benefits.
