Case Study
Background
An established mold injection and SMT company who strategically decided to change into the medical device area as an international contract manufacturer.
Challenges
- Transfer of the old factory into a state of the art controlled clean room facility (ISO 5, ISO 7, ISO 8 )
- Clean room facility design
- Document control establishment according to the quality standards regulation
- Medical device GMP training
- Clean rooms training
- Medical device prototype development
- Medical device process development
- Medical device prototype validation
- Medical device process validation
- Medical device quality system establishment
- Policies, SOP’s and controlled documents writing
- Medical device design qualification
- Good Engineering Practice
- Good Automation Practice
- Computerized System Validation
- Medical device software validation
- GMP audits according to FDA/CE standards
- Medical device ISO 13485 certification
- Infrastructure and utilities qualification including clean rooms
- Medical device manufacturing process engineering
- Equipment and machinery purchasing
- Equipment and machinery validation
- Medical device cleaning validation
- Medical device sterilization validation
- Medical device shipment validation
- Medical device packaging validation
- Validation protocols writing (installation qualification, operational qualification, performance qualification).
- Validation execution
- Medical device manufacturing batch record establishment and parameters optimization
- QP audit pre FDA registration
- Medical device manufacturing for clinical studies
Testimonials
“Bio-Chem led us transforming to Medical Device field. Project included clean rooms, facility design, qualifications and GMP. I enjoyed their excellent professionalism and commitment. Project completed in satisfactory quality level and in a timely manner”
Quality Assurance manager Medimor Medical Ltd
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