your partner in quality management and regulatory affairs
Quality management systems
Validation
Product registration and launch
Range of services
Consulting
Quality Management Systems
Implementation & Audit
ISO 13485:2016
ISO 9001:2015
MDSAP
Quality Risk Management
ISO 14971:2012
FMEA
Regulatory Affairs
Product Registration
Technology Transfer
New Product Introduction
Method Transfer
Validation
Product Validation
Process Validation
Shipping Validation
Equipment Qualification
Computer System Validation
Method Validation
Quality Assurance
CAPA
Complaint Handling
Change Control
Deviation Management
Root Cause Analysis
Supplier Management
Training
We can provide any training regarding quality assurance, validation and regulatory affairs. Here is a selection from our range:
MDR EU Regulation on Medical Devices 2017/745
IVDR EU Regulation on In Vitro Diagnostics Devices 2017/746
Quality Management Systems for Medical Devices according to ISO 13485:2016
Quality Risk Management and FMEA according to ISO 14971:2012
GAMP 5 (Good Automation Manufacturing Practices)
Validation of processes, transport, equipment and computer systems
GMP (Good Manufacturing Practices)
CAPA and Root Cause Analysis
Who are we?
Murielle Meunier, bio-engineer with ambition for improving lives
Her expertise lays in Quality Management Systems, Product Registration, Product Development, Risk Analysis, Validation, Process Engineering and Automation in the fields Pharmaceuticals, Medical Devices and In Vitro Diagnostics. She is an experienced Prince 2 certified project manager. Murielle offers quality support, advice and training in all items above and beyond. She is a good communicator, a dedicated professional and delivers projects with great enthusiasm, creativity and ambition.
Keen to know more?
Fill in our contact form and we’ll come back to you as soon as possible.