ISO 13485 Quality Management

Carbide is a tech-enabled service that strengthens your company’s information security and privacy management capabilities. Our platform and expert services are tailored for companies aiming for a sophisticated security posture, particularly valuable for organizations that must meet rigorous compliance requirements of security frameworks like SOC 2, ISO 27001, HIPAA, GDPR, and more. With Carbide, you can benefit from continuous cloud monitoring and the educational resources of Carbide Academy. Our platform supports over 100 technical integrations, enabling efficient evidence collection and meeting of security framework controls necessary for passing audits.

Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work Orders