Case Study

Field: Medical device


An established mold injection and SMT company who strategically decided to change into the medical device area as an international contract manufacturer.


  • 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


“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”

Sagi Ofer
Quality Assurance manager Medimor Medical Ltd

Bio-Medical and Cosmetic Operational Excellence, Process Efficiency and Quality level improvement projects. Minimizing time waste and rejected products, reducing setup and cleaning process times and maximizing process yields using 6-Sigma, 5S, best lean etc


New Bio-Med facilities projects management, design and manufacturing technologies. Regulatory requirements analysis, Good Engineering and Manufacturing practices consultancy. Escort until successful regulatory bodies audit and certification

FDA/Eu/ISO regulatory compliance consultancy. Quality System establishment, Quality policies/Good Practices integration and training. Quality improvement projects, GMP materials and components suppliers, manufacturing and shipment certification

Software, analytical methods, equipment, manufacturing and cleaning Verification & Validation consulting for Pharmaceutical/Medical products development, production, packaging, sterilization, storage & shipment

New Drugs, Medical Devices prototype and Cosmetics FDA/Eu submission, regulatory requirements analysis, files preparation, regulatory strategy, registration consultancy until certification and marketing approval

Bio-Medical Engineers and Bio-Pharmaceutical researchers escort, support and consultancy from new Medical Device / drugs development until clinical trials, manufacturing technologies development, scale up and GMP certification