Engineering and Design Services
Design Control and Planning
Design cycle including design planning and control
Product development through the design cycle.
Risk Analysis per ISO 14971.
Strategic Planning for Quality Management Systems (QSR and ISO 13485), manufacturing and regulatory pathways.
Management of Engineering Studies
Management of preclinical engineering feasability studies and performance testing.
Facility Design and Management
Design, planning and development of medical device manufacturing facilities including Class 100 to Class 10,000 cleanrooms and micro electronic assembly.
Sterilization Validation protocols and reports.