Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.
Build a world class eQMS that embeds lasting compliance, from documents and design controls to training and events.
Work with our team of seasoned quality experts to ensure you meet - and exceed - your QA goals every time.
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
For businesses independently building their eQMS from scratch with templated content
For businesses needing support to apply and adapt their new templates
For businesses integrating templates into an existing quality management structure
Additional support projects led by seasoned life science quality veterans