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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 means complying 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.

Participation in organizations such as AAMI, ASQ Biomedical Division, and MassMEDIC, enables me to remain abreast of emerging trends and proposed changes to regulations, guidance documents, and standards.

In addition, I am actively involved in developing standards and guidance documents for industry. I was a member of the working group that recently developed guidance for MDDS developers - published as AAMI SW87:2012 Recommended Practice for the Application of Quality Management System concepts to Medical Device Data Systems (MDDS).
Working collaboratively with your staff, I can help increase the effectiveness of your organization by:

  • Assessing your procedures for compliance with applicable regulations, guidance documents, and standards
  • Creating flexible processes based on accepted industry practices that can then be tailored to meet the unique needs and constraints of each project
  • Providing customized on-site training in a variety of skills related to software development, software verification and validation, risk assessment, and other topics...

Using my years of software engineering and medical device expertise, I interpret FDA regulations and guidance documents from a software perspective and provide clients with information they need to not only comply but to develop devices in a manner that is both safe and cost-effective. Some areas where my consulting expertise can help include:
  • Review and assess existing SOPs and Work Instructions
  • Prepare SOPs and Work Instructions on all topics related to software and Design Controls
  • Assess software development processes
  • Assess software verification processes
  • Assess software validation processes
  • System Risk Assessment and Hazard Analysis, including Fault Trees and FMECAs
  • Software project planning, including task estimation and scheduling
  • Assess compliance with QSR, Design Controls, Part 11, Risk Management (ISO 14971) and IEC 62304
  • Develop embedded software for medical devices
  • Prepare of software-related information for 510(k) submission
  • Mentor and coach SQA and Quality Assurance staff
  • Assist RA/QA staff in device submissions
  • Assist in responding to software-related 483 issues
  • Third party software supplier qualification and management
  • Third party and off-the-shelf software tool qualification and validation
  • Configuration management, defect tracking, and corrective action (CAPA)
  • Issues related to networked medical devices per IEC 80001

My experience in software engineering, medical device software development, training, and auditing, can help identify those aspects of your development process that need to be brought into compliance with the regulations, guidance documents, and standards.

arrow Click here for brief summaries of selected consulting engagements.

arrow Click here for links to FDA Regulations and Guidance documents.




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