Ensuring cost-effective, timely, high-quality and medical-device compliant development processes
Particles of Services for Medical Device Vendors
Regulations and Standards Implementation of regulations and standards with the goal of certification/registration of a medical device (ISO 13485, 21 CFR 820, Medical Device Directive 93/42/EEC, Medical Device Regulation EU 217/745, IEC 60601 series, IEC 62304, IEC 62366, ISO 14971, ...)
Development Processes Definition of medical device compliant development processes
Quality Processes Establishment and implementation of risk management, usability, and quality management processes
Requirements Management Medical device compliant creation and tracking of system requirements
Verification & Validation Creation and implementation of verification and validation processes and tests
Documentation Medical device compliant creation of technical documentation
Authorities Dialog with authorities and notified bodies (national and international)
Project Management Project management for medical device development and manufacturing