In 2024 I helped 19 clients on multiple projects with their medical device software quality and regulatory needs. But I didn’t do it alone. I worked with engaged clients and other detail-orientated consultants to complement and assist each other to provide the best possible results.
Cybersecurity
I helped eight clients with their cybersecurity documentation from creating cybersecurity risk analyses to cybersecurity views to identifying penetration testing partners and all other requirements from the FDA cybersecurity guidance documents. Some of the work was for initial regulatory submissions and some of the work was in response to Additional Information Requests from the FDA. I also had the unique experience of presenting at the Utah Life Sciences Summit about cybersecurity.
510(k) Submissions
I helped four clients complete their 510(k) submissions. The projects ranged from Software as a Medical Device to combination products with a software element.
QMS Processes
I helped eight clients create robust software and cybersecurity life-cycle processes. Some of the projects also included tailoring their QMS to meet the specific needs for companies that only create Software as a Medical Device. I also assisted in writing clean room procedures and a risk management gap analysis.
Design Strategy and Documentation
I helped nine clients create design control documentation such as general strategy plans, safety risk analysis, requirements, design reviews, verification and validation protocols and reports, and post-production plans.
On-site Auditing
I conducted an on-site audit, including a detailed report of the findings, for a contract manufacturer to determine their readiness for an FDA audit.
Are you struggling with your medical device software quality or regulatory? We can help.
