Effective and efficient solutions for your medical device
Quality Management
From Audit preparation to establishing a completely new QMS
- Slim QMS for small companies and start-ups
- QMS (e.g. ISO 9001, ISO 13485, QSR, MDSAP)
- Internal Auditing and Gap Analysis
- Audit Remediation Projects
Product Development/Technical Documentation
Documentation from the first idea to registration and successful market launch
- Validation of product and processes
- Traceability management of specifications
- Software and Hardware
Risk Management
- Introduction of an ISO 14971-compliant Risk Management process
- Creation of risk analyses and FMEAs
- Support in creating a Risk Management File
Certification
- Support of CE – marking process
- Clarification of international approval requirements
- Support in drafting of registration dossiers (e.g. FDA 510(k))
Trainings & Workshops
- Training of QMS documents
- GDocP – Training
- Risk Management workshops