Engineering services at any stage of development from concept to final production

• Specification development/reverse engineering

• Prototypes

• Documentation, including detailed parametric models, assembly drawings, part/component drawings, illustrated manuals, process mapping and flowcharts, detailed work instructions, SOP's

• Testing and evaluation, including mechanical and analytic methods

Remediation of product design, quality or manufacturing systems to ISO 13485/21 CFR 820 requirements

• Auditing and gap analysis, failure analysis

• Specification, manufacturing process and supplier audits/reviews

• Design for manufacturability

Remedial validation of product/process/test methods

• Product v&v testing, from product performance to final package and transport testing

• Process IQ/OQ/PQ.  Facility, process and software validation from protocol to final report

• Test method validation of in-process and final acceptance testing

Development, design, construction and validation of clean manufacturing spaces to ISO 14644 and EC requirements

• Concept based on current and future manufacturing requirements

• Design, including detailed facility requirements and microbial monitoring procedures

• Construction supervision and management

• Final commissioning and validation

• Ongoing monitoring and re-validation

New process design, development, validation and implementation

• Concept through to implementation and validation

New quality system development and implementation

• Auditing and gap analysis

• Risk analysis

• Implementation and verification of effectiveness against quality metrics

CAPA investigation and close-out, including root-cause investigation and detailed failure analysis

• Problem mapping and root cause analysis to verification of effectiveness

• Trained in Kepner-Tregoe (KT) analysis, Taguchi techniques (Philip Ross), DOE (Air Academy)