Quality and Engineering:
- Life Science Consulting
Are you looking for help with
- Production setup
- Technical / Design transfer
- Handling risk according to MDR
- Robust Design / Design for Manufacture
- Validation / Verification / Qualification
- Data analysis and statistics
for Medical Devices, within Biotech or in the Pharmaceutical industry?
Or do you need an extra hand with Quality tasks in your QMS system?
Q&E is your Life Science Swiss-army knife!
Process Design | Robust Design | Design for Manufacture | Commissioning/Upscaling of pilot equipment to full scale production systems | Validation and Verification | Design Control | Tech Transfer | Lean tools | Statistical methods
GMP compliance | QMS (ISO 9001, ISO13485) | Quality planning |Risik Management (ISO14971) | Problem Solving (e.g. Root Cause Analysis) | Compliance
Design of Experiments (DoE) | 6-sigma Tools | Data Analysis |Process Control (SPC) | Sample Size Planning
