our services
Kaizen process audits
Short-term process audits of manufacturing assembly lines for Class III devices (stents and catheters)
Supplier audits
Audits of vendors and suppliers to assess qualifications as a approved suppliers.
Setting up quality systems
Helping medical device start-ups and smaller biotechnology companies setup and implement an entry-level or full-scale QMS based on client and customer outputs.
FDA visit preparation
Preparing clients such as medical device and biotech companies for anticipated FDA visits. Mock audits, protocol, and documentation preparation.
Backlog QA projects
Complaints. Recalls, CAPA’s, Audit responses, and MDR processing for Class II and Class III clients.