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Examples of past consulting engagements

The following are a few examples of past consulting engagements with Medical Device companies.

For a robotic endoscope start-up:
I reviewed the software development process and recommended several changes to procedures and practices to ensure compliance with FDA guidance documents. I performed supplier audits for third party software suppliers. I reviewed the risk management tables and recommended changes to the information presented in the tables to comply with IEC 14971. I also provided staff with tailored training in software development and risk management.

For a world-class Boston hospital and several small start-ups:
I prepared an FDA-compliant Quality Management System that would enable the hospital to develop MDDS devices in compliance with the MDDS Rule and AAMI SW87:2012 Recommended Practice for the Application of Quality Management System concepts to Medical Device Data Systems (MDDS).

For several mobile health start-ups:
I developed an FDA-complaint Quality Management System including a Quality Manual and a complete set of Standard Operating Procedures covering topics such as: Design Controls, Software Development, Risk Management, Complaint Handling and MDR Reporting, CAPA, Production and Service Controls, Purchasing and Supplier Controls, Document and Record Controls, Verification and Validation, Internal and External Audits, Control of Nonconforming Product, and Design Reviews.

For an international IVD manufacturer:
I audited several projects and identified several areas of potential regulatory exposure. I also provided staff with tailored training in software development and software validation.

For a Japanese medical device manufacturer:
I reviewed their imaging device from a software and FDA compliance perspective. Based on my feedback, I was asked to travel to Chennai India where I performed a compliance audit of a software development contractor.

For a German orthopedic device manufacturer:
I reviewed the software used in manufacturing (CNC machines) to identify potential compliance issues in preparation for a PMA Inspection.

For several UK medical device manufacturers:
I reviewed their Quality Management System and SOPs for compliance with FDA requirements. I provided recommendations on how to improve their procedures to help them become more effective and more compliant.

For a mid-size biotech:
I helped plan and implement a database migration strategy to move a terabyte database from Sybase to Oracle. I planned and oversaw the validation strategy that ensured the integrity of the migration process and the accuracy of the data post-migration.

For a managed healthcare provider:
I reviewed the software development processes used by the IT Staff in developing software for running the business. As a result of this review, I developed a custom on-site training session that focused on writing and reviewing requirements, peer reviews, and testing against requirements. I also provided training for executives on the importance of having a Predictable Software Development™ process.

For a medical device manufacturer:
I performed an assessment of the software development practices used by the IT Staff in developing software for manufacturing. As a result of this assessment, I provided an on-site training session in software development for medical device manufacturers, provided training in basic software validation practices, provided training in work flow diagrams for manufacturing staff, and wrote test procedures based on revised SOPs that incorporated work flow diagrams.

For a health services company:
I performed a due diligence audit as part of an acquisition. Working with the acquiring company's attorneys, I provided a factual assessment of the state of the company being considered for acquisition with regard to compliance with relevant FDA regulations and guidance documents.

For several medical device start-ups:
I provided examples of standard operating procedures in key areas needed for FDA compliance. Working with the staff, I helped tailor these SOPs to reflect how tasks were performed. The results proved to be very beneficial in helping to get these companies off in the right direction.

For a large DoD contractor:
I provided guidance on developing software for a military blood bank application. This included working with the Project Team to develop a more realistic set of SOPs, on-site training for the Test Team, and mentoring and coaching for the QA Team. In addition, I helped the QA Team perform more effective internal audits, and helped the organization prepare for and respond to an FDA Inspection.

For a large medical device manufacturer:
I provided guidance in how to perform Software Validation. On several different projects, I acted as the Software QA Lead and prepared the Test Plan, wrote many test scripts, and was actively involved in executing tests, reporting defects, and performing regression testing.

For a blood bank software company:
The client was struggling with ways to define requirements for a new product that was desperately needed. As is typical, they had lots of clinical expertise but little software development skills. To address this, I showed them how Use Cases could be used to define user requirements in a manner that was based on actual user workflow. The Use Case diagrams were then used as the basis for developing the requirements and validation tests.