About
Robert House
I have more than 20 years of experience leading technology, data and client delivery. I led software at a medical device company through ISO 13485 and MDSAP audits, so I know what an auditor samples and what your engineers can maintain.
I now help device startups build design controls, risk files and software lifecycle records that hold up at their first audit, and I provide internal audits under clause 8.2.4.
Experience and credentials
Background that matches the work.
- Software lead at a medical device company through ISO 13485 and MDSAP audits Experience
- Technology and data strategy leadership 20+ years
- IEC 62304 software lifecycle and SaMD development Practice
- Canadian privacy compliance: PIPEDA and Québec Law 25 Practice
- ISO 13485 lead auditor training [Add on completion]
Working agreements
What you can expect on every engagement.
Written scope first
Scope, timeline and fee are agreed in writing before work starts.
I do the work myself
The person on the scoping call is the person delivering the engagement.
Confidential by default
A mutual confidentiality agreement is available before any documents change hands.
You own the results
Every document, workflow and dashboard is handed over with the guides your team needs.
Recommendations
What people say about working with me.
Excerpts from recommendations on my LinkedIn profile.
“Rob has a strong grasp of business needs and always takes the time to fully understand the problem to be solved. His recommendations are thoughtful, practical, and grounded in both technical expertise and real-world application.”
“Rob brings a rare combination of technical depth, strategic thinking, and practical execution. He is able to take complex business needs, technical requirements, and stakeholder priorities and turn them into clear, actionable solutions.”
“Robert played a key role in shaping solutions and ensuring smooth, on-time delivery for our projects. His expertise and responsiveness make him a dependable and true partner.”
“He is not a yes-person, and will tell you what can and cannot happen so that expectations can be met.”
Start with a conversation.
A 30 minute call. No preparation needed.