Lean Processes in Medical Technology

inmedis is your partner of choice if you need competent support in quality management and regulatory affairs within medical technology. Our experts offer advice and support with certifications, staff shortages and many other QM/RA topics in order to enable you to reach your goals faster.


QM-Systems

ISO 9001 / ISO 13485 / FDA QSR

Audits / MDSAP


QM-Management

Outsourcing of QM/RA-Functions

Coaching and Support


Technical Documentation

MDR-compliant Documentation

Gap-Analysis / Reviews



Validation

Design and Manufacturing Processes
Computer Systems (CSV)


Biocompatibility

Planning and Execution

ISO 10993


Product Approval

Submission Strategy

Coordination with Authorities