services

The following services are available with special emphasis on regulated industries including Medical Device, Pharmaceutical, and Defense.

Project Managment and Continuous Improvement

Hands-on implementation of leading-edge project management techniques for technologically advanced products integrating software, electrical, mechanical, and scientific disciplines across geographically dispersed teams.

 

Definition, selection, and implementation of process improvement initiatives in all aspects of software management, development, and test. 

Agile

Start up and optimize Agile fundamentals including: estimation, backlog management, release and sprint planning, metrics (capacity, velocity, burn-down, burn-up, earned value), daily standups, sprint reviews, and retrospectives. Work with organizations and teams to create a best-fit Agile lifecycle from Scrum to Kanban to hybrid models which also transition from, or integrate with, waterfall lifecycles.

Team Coaching and Training

Help teams be more focused and more effective using high value software processes.

Quality Managment

Management and design of software verification and validation programs leading to successful global launch of high quality software and hardware products which meet or exceed business objectives and external regulatory standards (ISO, IEC, FDA).

Risk Management

Implementation of informative, effective, value-added processes for project risk management including semi-quantitative risk analysis and product risk management including Hazard Analysis and FMEA.

Regulatory Compliance

Leadership in analyzing and implementing regulatory requirements and quality management systems including FDA 21 CFR 820.30 (Design Controls), IEC 62304 (Medical device software), FDA 21 CFR 807.87 (510 k), 21 CFR Part 11 (Electronic Records and Signature), HIPAA, GAMP, EU Annex 11, ISO 9001, CMMI, and ISO 13485.

Computer Systems Validation (CSV)

Validation and cGMP compliance of computer systems used in medical device and pharmaceutical operations and quality management systems with special emphasis on risk assessment and electronic records compliance.

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