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Consulting Services for the Medical Device Industry

Developing safety critical software for medical devices or using software as part of a manufacturing process requires compliance with FDA regulations, guidance documents, and international standards. Many companies have difficulty interpreting the regulations and guidance documents in a way that is meaningful for the software embedded in their devices.

As a software engineer with 25 years of medical device experience, I help clients understand FDA regulations, guidance documents, and international standards. I have worked with over 75 medical device, biotech and pharmaceutical companies on a wide array of devices (including Class I, II, and III). I have also performed many audits and helped many clients respond to FDA 483 warning letters. This experience has enabled me to understand what is expected in terms of procedures, documentation, and records.

Consulting Services for the Nuclear Power Industry

I have been actively involved in the commercial grade dedication (CGD) process for safety related digital equipment and plant engineering design and analysis software. Working with third-party dedicators, I have participated in developing dedication processes that provide reasonable assurance that commercial grade digital systems will perform intended safety functions in nuclear plants as well as meet all regulatory requirements for items relied on for safety (IROFS).

Safety related digital equipment is dedicated based on a CGD Plan developed specifically for the project. Activities such as verification and validation, supplier surveys, risk assessments and hazard analysis using FMEAs and Fault Trees, audits, reviews and inspections are often performed to provide confidence and documented evidence that the equipment will perform satisfactorily in safety related applications.

Consulting Services for the Transportation Industry

Much of the transportation infrastructure is controlled and managed by safety-critical software. Many safety-critical practices used in other safety-critical industries are applicable to the transportation industry. In addition, there may also be federal and state regulations and contractual requirements that apply.

As a software engineering with over 35 years of experience, I can help transportation organizations protect their significant investments in safety-critical signaling and control system software by performing risk assessments and identifying safety cases, by monitoring the work of software subcontractors, and by introducing proven software engineering practices.

Consulting Services for Mission-Critical Projects

Many software organizations develop mission-critical projects—those projects where the software must work reliably and consistently. While not safety-critical in nature, many of the techniques and practices used for safety-critical software can be adapted and applied for mission-critical projects.
For example, software reliability modeling techniques can also be used to provide a qualitative assessment of reliability when appropriate. Safety cases can be used to provide assurance that software applications can meet project objectives.

My experience in software engineering, safety-critical software development, training, and auditing, can help identify those aspects of your development process that can be improved to meet your mission-critical project needs.

Getting Started

Every consulting engagement begins with an in-depth discussion of the client’s situation and ways I can assist. Brainstorming sessions, interviews, and audits are some examples of tools and techniques I use to ensure that the issues are clearly identified. Once this happens, a detailed action plan is prepared, reviewed, and approved by the client.

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