Medical Device Quality Management System Consulting Services
Qualomics was founded in 2017 to bring quality assurance and management to small companies and start-ups. We specialize in right-sized QMSs and creative solutions for companies that don't yet have the need for a full-time QA resource. We also offer supplier and vendor qualification audits and evaluations and internal audit services. We can help with initial QMS implementation, QMS improvements and routine QA. We have experience with class I and class II IVDs and devices in cardiology, nephrology, oncology, infectious disease, women's health and orthopedics.
We have experience with ISO 13485, 21 CFR 820 (QSRs), medical device GMPs, MDSAP audit model and design controls.
We also offer services related to Good Tissue Practices (GTP) and tissue banking under AATC, BAP and ISO 20387.
We do not prepare FDA or EU submissions, but rather focus on regulatory compliance within your company.