Medical Device Projects
New Product Design and Development
· Product Upgrade Engineering
· Molded Plastic Part Design: SolidWorks CAD models with rapid prototype parts
· Drawing Reviews
· Design Reviews
· Design variation stress calculations for an electronic component

· New device Validation Master Plan
· Product Validation
· Standard Operating Procedures (Corporate level through process)
· Technology Literature Searches
· Process Validation

· Failure modes analysis in medical device clinical test product
· Device product design verification studies
· Component tolerance studies for plastic and metal parts
· Testing of modified products including Protocols and Test Reports

Materials
· Chemical characterization of product materials
· Bio-compatibility studies
· Materials Toxicity Assessment (literature searches)
· Product Materials Selection
· Accelerated Aging
· Materials failure modes analysis in medical device clinical test product

Process
· Product design and process improvement opportunity identification
· Product process validation plans
· Manufacturing process optimization to customer requested CpK
· Product design and process improvement opportunities (Malaysian facility)
· CAD tooling design for new process concepts

· Manufacturing yield loss analysis
· New manufacturing processes
· Statistically based validation protocols, testing, and reports (IQ, OQ, PQ)
· Process improvement Design of Experiments studies
· Molded Plastic Part Failure
· Manufacturing Process Standard Operating Procedures

Litigation
· Litigation product failure analysis
· Design Patent Litigation technical support



Pharmaceutical and Biotech Projects
Drug Development
· Design of Experiments - Computer modeling drug delivery mechanisms
· Pharmaceutical QA Assay SOP

Audits
· Pharmaceutical GLP Audit SOP
· Pharmaceutical GCP Audit SOP
· Pharmaceutical GMP Audits
· GCP Master Schedule Database creation
· Pharmaceutical GLP Audits
· Pharmaceutical GCP Audits